FDA 510(k) Applications for Medical Device:
Dilator, Vessel, For Percutaneous Catheterization
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K062554 | ABBOTT VASCULAR INC. |
400 SAGINAW DR. | REDWOOD CITY | CA | 94063 |
| K103421 | ARSTASIS, INC. |
1021 HOWARD AVE | SAN CARLOS | CA | 94070 |
| K151877 | ARSTASIS, INC. |
6500 KAISER DRIVE | FREMONT | CA | 94555 |
| K081940 | AVALON LABORATORIES, LLC |
2610 E. HOMESTEAD PLACE | RANCHO DOMINGUEZ | CA | 90220 |
| K201288 | Baylis Medical Company Inc. |
2580 Matheson Blvd. East | Mississauga | L4W 4J1 | |
| K182064 | Baylis Medical Company Inc. |
2775 Matheson Blvd. East | Mississauga | L4W 4P7 | |
| K150932 | BIOTEQUE CORP. |
5 F-6, NO. 23, SEC. 1 | TAIPEI | 104 | |
| K974640 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K162181 | CARDIACASSIST INC. |
240 ALPHA DRIVE | PITTSBURGH | PA | 15238 |
| K183036 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K210734 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K170616 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K010055 | COOK VASCULAR, INC. |
RT. 66, RIVER RD. | LEECHBURG | PA | 15656-0529 |
| K061000 | COOK VASCULAR, INC. |
1186 MONTGOMERY LANE | VANDERGRIFT | PA | 15690 |
| K142301 | COOK VASCULAR, INC. |
1186 MONTGOMERY LANE | VANDERGRIFT | PA | 15690 |
| K141148 | COOK VASCULAR, INC. |
1186 MONTGOMERY LANE | VANDERGRIFT | PA | 15690 |
| K070749 | COOMBS MEDICAL DEVICE CONSULTING |
1193 SHERMAN STREET | ALAMEDA | CA | 94501 |
| K970392 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K093554 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K974617 | ENDOVASCULAR INSTRUMENTS, INC. |
1800 EAST 900 SOUTH | SALTLAKE CITY | UT | 84108 |
| K172487 | Galt Medical Corp. |
2220 Merritt Dr. | Garland | TX | 75041 |
| K071330 | GALT MEDICAL CORP. |
2220 MERRITT DR. | GARLAND | TX | 75041 |
| K192195 | Galt Medical Corp. |
2220 Merritt Dr. | Garland | TX | 75041 |
| K970470 | GUIDANT CARDIAC AND VASCULAR SURGERY |
1360 O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K082075 | HANSEN MEDICAL, INC. |
800 E. MIDDLEFIELD ROAD | MOUNTAIN VIEW | CA | 94043 |
| K123842 | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
LANGSHAN 2ND STREET | SHENZHENG, GUANGDONG | 518057 | |
| K963388 | MAXXIM MEDICAL |
100 EAST 15TH ST. | FORT WORTH | TX | 76102 |
| K182914 | MC3 Incorporated |
2555 Bishop Circle West | Dexter | MI | 48130 |
| K945586 | MED INSTITUTE, INC. |
P.O. BOX 2402 | WEST LAFAYETTE | IN | 47906 |
| K162389 | MEDCOMP ( MEDICAL COMPONENTS) |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K192283 | Medron, LLC |
1518 S Gladiola Street | Salt Lake City | UT | 84104 |
| K190175 | Merit Medical Systems Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K031691 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K091584 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K050962 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K232609 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K073035 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K070159 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K130791 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K123445 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K132713 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K960917 | SCIENTIFIC DEVICE MANUFACTURER LLC. |
999 ANDERSEN DRIVE, SUITE 120 | SAN RAFAEL | CA | 94901 |
| K140047 | SPECTRANETICS CORP. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K092378 | SPECTRANETICS CORP. |
96 TALAMINE CT. | COLORADO SPRINGS | CO | 80907-5159 |
| K133631 | SPECTRANETICS CORPORATION |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921-3617 |
| K223472 | Spectranetics Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K212784 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K141131 | SPECTRANETICS, INC. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K150360 | SPECTRANETICS, INC. |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921 |
| K142546 | SPECTRANETICS, INC. |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921 |
| K161333 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K151076 | Summit Access, LLC |
14 Inverness Drive East, Suite H-136 | Englewood | CO | 80112 |
| K200379 | TOGO MEDIKIT CO., LTD. |
17148-6 Aza Kamekawa, Oaza Hichiya | Hyuga City | 883-0062 | |
| K141070 | TOGO MEDIKIT CO., LTD. |
4-1-17 HONGO | BUNKYO-KU | 113-0033 | |
| K052557 | TOGO MEDIKIT CO., LTD. |
5905 NATHAN LANE | PLYMOUTH | MN | 55442 |
| K120349 | ULTRASONIX MEDICAL CORPATION |
130-4311 VIKING WAY | RICHOND, BC | V6V 2K9 | |
| K980282 | URESIL CORP. |
5418 W. TOUHY AVE. | SKOKIE | IL | 60077 |
| K161336 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT NORTH | MINNEAPOLIS | MN | 55369 |
| K030260 | VASCUMETRIX, LLC |
1058 N. HIGLEY RD. #204 | MESA | AZ | 85205 |
| K012256 | VASCUMETRIX, LLC |
2824 N. POWER RD. | MEAS | AZ | 85215-1674 |
| K023507 | VASCUMETRIX, LLC |
2824 NORTH POWER RD., #113-278 | MESA | AZ | 85215-1674 |
| K211679 | Xcardia Innovation Ltd. |
1 Hamada Street | Rehovot | 7670301 | |
| K000737 | XENTEK MEDICAL, INC. |
6136 FM 1616 | ATHENS | TX | 75751 |
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