FDA 510(k) Applications for Medical Device:
Clamp, Vascular
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K072167 | ADVANCED VASCULAR DYNAMICS |
2326 NW EVERETT ST. | PORTLAND | OR | 97210 |
| K040615 | ADVANCED VASCULAR DYNAMICS |
2326 NW EVERETT ST. | PORTLAND | OR | 97210 |
| K090286 | ADVANCED VASCULAR DYNAMICS |
1910 NW 23RD PLACE | PORTLAND | OR | 97210 |
| K142122 | ADVANCED VASCULAR DYNAMICS |
4252 SE International Way Ste F | Milwaukie | OR | 97222 |
| K092503 | ADVANCED VASCULAR DYNAMICS |
1910 NW 23RD PLACE | PORTLAND | OR | 97210 |
| K151363 | ADVANCED VASCULAR DYNAMICS |
4252 SE INTERNATIONAL WAY, STE. F | MILWAUKIE | OR | 97222 |
| K992053 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K974769 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K991589 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K011078 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K972689 | ANLAM CORP. |
10536-101 ST. | EDMONTON, ALBERTA | T5H 2R8 | |
| K002915 | APPLIED MEDICAL |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K962668 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K161315 | AROS Surgical Instruments Corporation |
2111 Descanso | Newport Beach | CA | 92660 |
| K222182 | Beijing Demax Medical Technology Co., Ltd. |
101, Floor 1-3, 13-7A Jingshengnansi Street, Beijing | Beijing | 101102 | |
| K981624 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K210006 | Biorep Technologies, Inc |
15804 NW 57th Avenue | Miami Lakes | FL | 33014 |
| K011208 | BIOVER AG |
252 W. RIDLEY AVE. | RIDLEY PARK | PA | 19078 |
| K980002 | BOSS INSTRUMENTS, LTD. |
1310 CENTRAL CT. | HERMITAGE | TN | 37076 |
| K130382 | Boston Scientific Corporation |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K033085 | CARDIO LIFE RESEARCH, S.A. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K070380 | CARDIO LIFE RESEARCH, S.A. |
220 RIVER ROAD | CLAREMONT | NH | 03743 |
| K980128 | CARDIO MEDICAL SOLUTIONS, INC. |
17080 NEWHOPE ST. | FOUNTAIN VALLEY | CA | 92708 |
| K123571 | CARDIOMEDICAL GMBH |
AMSTEL 320-1 | AMSTERDAM, NOORD-HOLLAND | 1017AP | |
| K963503 | CARDIOTHORACIC SYSTEMS, INC. |
10600 NORTH TANTAU AVE. | CUPERTINO | CA | 95014 |
| K970638 | CARDIOTHORACIC SYSTEMS, INC. |
10600 NORTH TANTAU AVE. | CUPERTINO | CA | 95014 |
| K010117 | CARDIOTHORACIC SYSTEMS, INC. |
10600 NORTH TANTAU AVE. | CUPERTINO | CA | 95014 |
| K072297 | CARDIVA MEDICAL, INC. |
155 MOFFETT PARK DR., | SUNNYVALE | CA | 94089 |
| K051817 | CARDIVA MEDICAL, INC. |
P.O. BOX 10925 | PLEASANTON | CA | 94588 |
| K061075 | CARDIVA MEDICAL, INC. |
2585 LEGHORN ST. | MOUNTAIN VIEW | CA | 94043 |
| K070485 | CARDIVA MEDICAL, INC. |
155 MOFFETT PARK DR., | SUNNYVALE | CA | 94089 |
| K082930 | CARDIVA MEDICAL, INC. |
155 MOFFETT PARK DR., | SUNNYVALE | CA | 94089 |
| K130124 | CARDIVA MEDICAL, INC. |
8 SNOWBERRY CT. | ORINDA | CA | 94563 |
| K041486 | CARDIVA MEDICAL, INC. |
P.O. BOX 10925 | PLEASANTON | CA | 94588 |
| K210324 | CareFusion 2200 Inc |
75 North Fairway Drive | Vernon Hills | IL | 60061 |
| K102025 | COMBAT MEDICAL SYSTEMS, LLC |
13417 QUIVAS ST | WESTMINSTER | CO | 80234 |
| K130482 | COMBAT MEDICAL SYSTEMS, LLC |
13417 QUIVAS ST | WESTMINSTER | CO | 80234 |
| K141685 | COMBAT MEDICAL SYSTEMS, LLC |
400 N. WASHINGTON STREET, SUITE 100 | ALEXANDRIA | VA | 22314 |
| K221661 | Compression Works Inc |
1634-A Montgomery Hwy #115 | Hoover | AL | 35216 |
| K112384 | COMPRESSION WORKS LLC |
15 SARGENT AVE | PROVIDENCE | RI | 02906 |
| K133029 | COMPRESSION WORKS, LLC |
15 SARGENT AVE | PROVIDENCE | RI | 02906 |
| K984214 | CORDIS NEUROVASCULAR, INC. |
14000 N.W. 57TH CT. | MIAMI LAKES | FL | 33014 |
| K062569 | DATASCOPE CORP. |
1300 MACARTHUR BLVD | MAHWAH | NJ | 07430 |
| K122405 | DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. | FAIRFIELD | NJ | 07004-0011 |
| K981956 | DEGANIA SILICONE, LTD. |
DEGANIA BET | EMEK HAYARDEN | 15130 | |
| K964547 | DEGANIA SILICONE, LTD. |
DEGANIA BET | EMEK HAYARDEN | 15130 | |
| K163693 | Edwards Lifesciences LLC |
One Edwards Way | Irvine | CA | 92614 |
| K112694 | EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy | Draper | UT | 84020 |
| K113182 | EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy | Draper | UT | 84020 |
| K132175 | EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy | Draper | UT | 84020 |
| K980631 | EMBOL-X, INC. |
645 CLYDE AVE. | MOUNTAIN VIEW | CA | 94043 |
| K192413 | Ensite Vacular, LLC |
10900 South Clay Blair Blvd, Suite 800 | Olathe | KS | 66061 |
| K190351 | Ensite Vascular |
10900 S. Clay Blair Blvd. | Olathe | KS | 66061 |
| K210681 | Ensite Vascular |
10900 S. Clay Blair Blvd. | Olathe | KS | 66061 |
| K990573 | ESTECH, INC. |
4115 BLACKHAWK PLAZA CIRCLE | DANVILLE | CA | 94506 |
| K123041 | FORGE MEDICAL INC. |
150 LEVINBERG LANE | WAYNE | NJ | 07470 |
| K153259 | FORGE MEDICAL, INC. |
701 W BROAD ST, SUITE 102 | Bethlehem | PA | 18018 |
| K982365 | GEISTER MEDIZINTECHNIK GMBH |
FOEHRENSTR. 2 | TUTTLINGEN | D-78532 | |
| K102048 | GEOMED MEDIZIN- TECHNIK GMBH & CO. KG |
UNTERER WINKEL 3 | WUMLINGEN | 78532 | |
| K022880 | GUIDANT CORP. |
3744 MT. DIABLO BLVD. | LAFAYETTE | CA | 94549 |
| K080169 | GUIDANT CORPORATION, CARDIAC SURGERY |
170 BAYTECH DRIVE | SAN JOSE | CA | 95134 |
| K962366 | HEARTPORT, INC. |
200 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K955132 | HEARTPORT, INC. |
200 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K962510 | HEARTPORT, INC. |
200 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K964161 | HEARTPORT, INC. |
200 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K962858 | HEARTPORT, INC. |
200 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K123077 | HEBU MEDICAL GMBH |
AMSTEL 320-1 | AMSTERDAM | 1017 AP | |
| K021608 | IMPLANTABLE DEVICES |
P.O. BOX 270882 | TAMPA | FL | 33688 |
| K071225 | INNOVASA, INC. |
16625 REDMOND WAY | REDMOND | WA | 98052 |
| K123551 | INNOVATIVE TRAUMA CARE INC |
3463 MAGIC DR. | SAN ANTONIO | TX | 78229 |
| K132651 | INNOVATIVE TRAUMA CARE INC |
3463 MAGIC DR. | SAN ANTONIO | TX | 78229 |
| K140805 | INNOVATIVE TRAUMA CARE INC |
3463 MAGIC DR. | SAN ANTONIO | TX | 78229 |
| K150813 | INNOVATIVE TRAUMA CARE INC |
3463 MAGIC DR. | SAN ANTONIO | TX | 78229 |
| K092544 | INSTRUMED INTERNATIONAL, INC. |
626 COOPER COURT | SCHAUMBURG | IL | 60173 |
| K131411 | JILIN CORONADO MEDICAL LTD. |
9 South-Western Circle Road | Jilin | 132016 | |
| K120492 | K2 MEDICAL GMBH & CO. KG |
UNTER BUCHSTEIG 3A | TUTTLINGEN | 78532 | |
| K014277 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K010785 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K111837 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
NO. 37 CHAOQIAN ROAD | BEIJING, CHANGPING DISTRICT | 102200 | |
| K142359 | Lepu Medical Technology (Beijing) Co., LTD |
No. 37 Chaoqian Road | Beijing | 102200 | |
| K132293 | MARINE POLYMER TECHNOLOGIES |
107 WATER STREET | DANVERS | MA | 01923 |
| K053300 | MARINE POLYMER TECHNOLOGIES, INC. |
107 WATER ST. | DANVERS | MA | 01923 |
| K061484 | MCPHERSON ENTERPRISES, INC. |
P.O. BOX 270882 | TAMPA | FL | 33688 |
| K062474 | MCPHERSON ENTERPRISES, INC. |
3851 62ND AVE. N. | PINELLAS PARK | FL | 33781 |
| K201695 | Medical Ingenuities |
345 Browning Court | Wheaton | IL | 60189 |
| K162027 | MEDTRONIC VASCULAR |
37A CHERRY HILL DRIVE | DANVERS | MA | 01923 |
| K112662 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K180723 | Merit Medical Systems, Inc |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K162988 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K982278 | MICRINS SURGICAL, INC. |
28438 BALLARD DR. | LAKE FOREST | IL | 60045 |
| K110148 | MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
540 COLLEGE STREET | BELLAIRE | TX | 77401 |
| K992640 | MINUMYS SURGICAL, INC. |
10231 BUBB RD. | CUPERTINO | CA | 95014 |
| K123194 | NORTH AMERICAN RESCUE PRODUCTS, INC. |
35 TEDWALL COURT | GREER | SC | 29650-4791 |
| K023682 | NOVARE SURGICAL SYSTEMS, INC. |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K032589 | NOVARE SURGICAL SYSTEMS, INC. |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K992980 | NOVARE SURGICAL SYSTEMS, INC. |
10231 BUBB RD. | CUPERTINO | CA | 95014 |
| K010727 | NOVARE SURGICAL SYSTEMS, INC. |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K010694 | NOVARE SURGICAL SYSTEMS, INC. |
10231 BUBB RD. | CUPERTINO | CA | 95014 |
| K000098 | NOVARE SURGICAL SYSTEMS, INC. |
10231 BUBB RD. | CUPERTINO | CA | 95014 |
| K970611 | ORIGIN MEDSYSTEMS, INC. |
135 CONSTITUTION DR. | MENLO PARK | CA | 94025 |
| K963716 | PERCUTANEOUS TECHNOLOGIES, INC. |
773 TROTTER COURT | WALNUT | CA | 91789 |
| K123035 | Perouse Medical |
135, ROUTE NEUVE | IRIGNY | 69 540 | |
| K992174 | PILLING WECK SURGICAL |
420 DELAWARE DR. | FORT WASHINGTON | PA | 19034 |
| K980087 | PRESSURE PRODUCTS, INC. |
30423 MIRALESTE DR. | RANCHO PALOS VERDES | CA | 90275 |
| K961100 | R.S.P. MEDICAL MANAGEMENT, INC. |
3722 AVE SAUSALITO | IRVINE | CA | 92714 |
| K983471 | RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | S-754 50 | |
| K024107 | RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | S-754 50 | |
| K980898 | RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | S-754 50 | |
| K982182 | RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | S-754 50 | |
| K080206 | RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | S-754 50 | |
| K973216 | RMDS, INC. |
1208 SE 104TH AVE. | VANCOUVER | WA | 98664-4740 |
| K970027 | RMDS, INC. |
1208 SE 104TH AVE. | VANCOUVER | WA | 98664-4740 |
| K964662 | RMDS, INC. |
1208 SE 104TH AVE. | VANCOUVER | WA | 98664-4740 |
| K964663 | RMDS, INC. |
1208 SE 104TH AVE. | VANCOUVER | WA | 98664-4740 |
| K955270 | ROBERT R. STEVENS |
15720 BULL RUN RD. #377 | MIAMI LAKES | FL | 33014 |
| K022754 | S & T AG |
28438 BALLARD DR. | LAKE FOREST | IL | 60045 |
| K131561 | SAM MEDICAL PRODUCTS |
27350 SW 95TH AVE STE 3038 | Wilsonville | OR | 97070 |
| K123694 | SAM MEDICAL PRODUCTS |
27350 SW 95th Ave Ste 3038 Bldg 30 | Wilsonville | OR | 97070 |
| K002767 | SEMLER TECHNOLOGIES, INC. |
501 S.E. COLUMBIA SHORES BLVD. | VANCOUVER | WA | 98661-8064 |
| K053398 | SEMLER TECHNOLOGIES, INC. DBA |
2326 NW EVERETT ST. | PORTLAND | OR | 97027 |
| K110193 | ST. JUDE MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | SE-751 35 | |
| K191827 | Sunny Medical Device (Shenzhen) Co.,Ltd. |
56 Lehigh Aisle | Irvine | CA | 92612 |
| K072834 | SURGICAL INSTRUMENTS BELGIUM SA |
220 RIVER RD. | CLAREMONT | NH | 03743-5647 |
| K143078 | SYMMETRY SURGICAL |
3034 OWEN DRIVE | ANTIOCH | TN | 37013 |
| K113600 | SYNEXMED (SHENZHEN) COMPANY LIMITED |
B-11/F,ZTY Buliding,TaoHuaRd, | SHENZHEN, GUANGDONG | 518038 | |
| K221843 | Synovis Micro Companies Alliance, Inc. |
(a subsidiary of Baxter International, Inc.) | Birmingham | AL | 35211 |
| K012041 | TENACORE HOLDINGS, INC. |
23266 VIA RONDA | MISSION VIEJO, | CA | 92691 |
| K070423 | TERUMO MEDICAL CORP. |
950 Elkton Blvd. | Elkton | MD | 21921 |
| K152525 | TERUMO MEDICAL CORPORATION |
950 ELKTON BLVD | ELKTON | MD | 21921 |
| K213531 | Terumo Medical Corporation |
950 Elkton Blvd | Elkton | MD | 21921 |
| K170958 | Tricol Biomedical Inc. |
720 SW Washington Street, Suite 200 | Portland | OR | 97205 |
| K173563 | TZ Medical Inc |
17750 SW Upper Boones Ferry Rd #150 | Portland | OR | 97224 |
| K973132 | TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY | LAKE OSWEGO | OR | 97035 |
| K964251 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K032125 | VASCULAR CONTROL SYSTEMS, INC |
32236 PASEO ADELANTO, STE. E | SAN JUAN CAPISTRANO | CA | 92675 |
| K031812 | VASCULAR CONTROL SYSTEMS, INC |
32236- E PASEO ADELANTO | SAN JUAN CAPISTRANO | CA | 92675 |
| K011863 | VASCULAR CONTROL SYSTEMS, INC |
32236- E PASEO ADELANTO | SAN JUAN CAPISTRANO | CA | 92675 |
| K023154 | VASCULAR CONTROL SYSTEMS, INC |
32236- E PASEO ADELANTO | SAN JUAN CAPISTRANO | CA | 92675 |
| K203307 | Vascular Graft Solutions, Ltd. |
24 Raoul Wallenberg St | Tel-Aviv | 6971921 | |
| K230248 | Vascular Graft Solutions, Ltd. |
24 Raoul Wallenberg Street | Tel-Aviv | 6971921 | |
| K063871 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT | MINNEAPOLIS | MN | 55369 |
| K050146 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT | MINNEAPOLIS | MN | 55369 |
| K040730 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT | MINNEAPOLIS | MN | 55369 |
| K070323 | VASCUTEK LTD. |
NEWMAINS AVE. | RENFREWSHIRE,GLASGOW,SCOTLAND | PA4 9RR | |
| K190318 | VASOInnovations Inc. |
1260 Huntington Drive, Suite 208 | South Pasadena | CA | 91030 |
| K203803 | VASOInnovations, Inc |
1260 Huntington Drive | South Pasadena | CA | 91030 |
| K070661 | VITALCOR, INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K973080 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K955827 | Y. DANESHVAR |
33433 SIX MILE RD. | LIVONIA | MI | 48152 |
| K961461 | Y. DANESHVAR |
33433 SIX MILE RD. | LIVONIA | MI | 48152 |
| K955742 | YOUSEF DANESHVAR |
33433 W. SIX MILE RD. | LIVONIA | MI | 48152 |
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