FDA 510(k) Applications for Medical Device:
Catheter, Straight
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103043 | ADAPTA MEDICAL, INC |
4250 GROVE STREET | DENVER | CO | 80211 |
| K161445 | ADAPTA MEDICAL, INC |
142 TALAMINE COURT | COLORADO SPRINGS | CO | 80907 |
| K181445 | Amsino International Inc. |
708 Corporate Center Drive | Pomona | CA | 91768 |
| K091306 | AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K113424 | ASTRA TECH AB |
11234 EL CAMINO REAL, | SAN DIEGO | CA | 92130 |
| K122078 | ASTRA TECH, INC. |
11234 EL CAMINO REAL, STE 200 | SAN DIEGO | CA | 92130 |
| K202566 | Big Blue Biotech, Inc. |
690 Canton Street, Suite 302 | Westwood | MA | 02090 |
| K212430 | Bonree Medical Co., Ltd |
No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang | Zhongshan | 528451 | |
| K041464 | BUSSE HOSPITAL DISPOSABLES |
PO BOX 11067 | HAUPPAUGE | NY | 11788 |
| K133470 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD | COVINGTON | GA | 30014 |
| K142575 | C.R. Bard, Inc. |
8195 Industrial Blvd | Covington | GA | 30014 |
| K112137 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K150345 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD | COVINGTON | GA | 30014 |
| K172247 | C.R. Bard, Inc. |
8195 Industrial Blvd | Covington | GA | 30014 |
| K030538 | CATHETER LLC. |
106 GROPPO DR. | WINSTED | CT | 06098-0917 |
| K212567 | Chengdu Daxan Innovative Medical Tech. Co., Ltd |
Unit 6, Building 1, No.18, North Bayi Road, | Chengdu | 611135 | |
| K230165 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K241028 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K221401 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K210250 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K203637 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K222059 | Coloplast |
1601 west river road north | MINNEAPOLIS | MN | 55411 |
| K241210 | Coloplast Corp |
1601 West River Road North | Plymouth | MN | 55411 |
| K233101 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K250270 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K242049 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55441 |
| K973070 | COLOPLAST CORP. |
1955 WEST OAK CIR. | MARIETTA | GA | 30062-2249 |
| K251116 | Coloplast Corp. |
1601 West River Road North | Minneapolis | MN | 55411 |
| K100878 | COLOPLAST MANUFACTURING US, LLC |
1601 WEST RIVER ROAD | MINNEAPOLIS | MN | 55411 |
| K140945 | COMPACTCATH INC |
3924 CASCADE BEACH ROAD | LUTSEN | MN | 55612 |
| K160858 | COMPACTCATH INC. |
887 FEDERATION WAY | Palo Alto | CA | 94303 |
| K180738 | Compactcath, Inc. |
887 Federation Way | Palo Alto | CA | 94303 |
| K250699 | Convatec |
First Avenue, Deeside Industrial Estate | Flintshire | CH5 2NU | |
| K232665 | ConvaTec |
First Avenue, Deeside Industrial Estate | Flintshire | CH5 2NU | |
| K230400 | ConvaTec, Inc. |
7815 National Service Road, Suite 600 | Greensboro | NC | 27409 |
| K221593 | ConvaTec, Inc. |
7815 National Service Road, Suite 600 | Greensboro | NC | 27409 |
| K072539 | CURE MEDICAL LLC. |
28241 CROWN VALLEY PARKWAY | LAGUNA NIGUEL | CA | 92677 |
| K110653 | CURE MEDICAL LLC. |
3722 AVENUE SAUSALITO | IRVINE | CA | 92606 |
| K132500 | CURE MEDICAL LLC. |
257 GARNET GARDEN STREET | HENDERSON | NV | 89015 |
| K211212 | Dentsply Sirona |
221 W Philadelphia Street, Suite 60W | York | PA | 17401 |
| K223756 | Dentsply Sirona |
221 West Philadelphia Street, Suite 60W | York | PA | 17401 |
| K103086 | DYNAREX CORPORATION |
10 GLENSHAW ST. | ORANGEBURG | NY | 10962 |
| K132619 | FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK | MID GLAMORGAN | CF45 4ER | |
| K090576 | FOOTPRINT MEDICAL |
1203 CAMDEN ST. | SAN ANTONIO | TX | 78215 |
| K222677 | Hangzhou Jimushi Meditech Co., Ltd. |
Bldg. 1, No. 12 Longtan Road, Cangqian Street, | Hangzhou | ||
| K213575 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K220667 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K233524 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K080007 | ICU MEDICAL, INC |
4455 ATHERTON DR. | SALT LAKE CITY | UT | 84123 |
| K973546 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K172541 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K100302 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K993226 | MEMCATH TECHNOLOGIES LLC. |
1777 OAKDALE AVE. | WEST ST. PAUL | MN | 55118-4031 |
| K050008 | MENTOR CORP. |
201 MENTOR DRIVE | SANTA BARBARA | CA | 93111 |
| K052440 | MENTOR CORPORATION |
201 MENTOR DRIVE | SANTA BARBARA | CA | 93111 |
| K072997 | NEOMED, INC. |
717 LAKEGLEN DR. | SUWANEE | GA | 30024 |
| K062444 | OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. |
208 BARRINGTON OVERLOOK | DURHAM | NC | 27703 |
| K040519 | PERCUTANEOUS SYSTEMS, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K061766 | PERCUTANEOUS SYSTEMS, INCORPORATED |
1300 CRITTENDEN LANE | MOUNTAIN VIEW | CA | 94043 |
| K122785 | ROCHESTER MEDICAL CORP. |
ONE ROCHESTER MEDICAL DR. | STEWARTVILLE | MN | 55976 |
| K151745 | SHAOXING FUQING HEALTH PRODUCTS CO., LTD. |
NO. 599 WUXIE ROAD, | SHAOXING | 312000 | |
| K023872 | VITALCARE, INC. |
15800 NW 13TH AVE. | MIAMI | FL | 33169 |
| K133615 | WELL LEAD MEDICAL CO. LTD |
445 APOLLO BEACH BLVD. | APOLLO BEACH | FL | 33572 |
| K220722 | Well Lead Medical Co., Ltd. |
No. 47 Guomao Avenue South, Hualong, Panyu | Guangzhou | 511434 | |
| K142563 | WELL LEAD MEDICAL CO., LTD. |
C-4#Jinhu Industrial Estate, Hualong, Panyu | Guangzhou | 511434 | |
| K123751 | WELLSPECT HEALTHCARE |
12264 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K170233 | Zhanjiang Star Enterprise Co., Ltd |
NO.1, West Jinhua Rd. | Zhanjiang | 524094 |
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