FDA 510(k) Applications for Medical Device:
System, Balloon, Intra-Aortic And Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K062582 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K070225 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K201112 | Arrow International Inc. |
16 Elizabeth Drive | Chelmsford | MA | 01824 |
| K200634 | Arrow International Inc. |
16 Elizabeth Drive | Chelmsford | MA | 01824 |
| K162820 | ARROW INTERNATIONAL, INC. |
16 ELIZABETH DR | Chelmsford | MA | 01824 |
| K190117 | Arrow International, Inc. |
16 Elizabeth Drive | Chelmsford | MA | 01824 |
| K190101 | Arrow International, Inc. |
16 Elizabeth Drive | Chelmsford | MA | 01824 |
| K232343 | Arrow International, LLC |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K192238 | Arrow International, Teleflex |
16 Elizabeth Drive | Chelmsford | MA | 01824 |
| K963865 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K963920 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K960713 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K993966 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K963104 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K965209 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K002256 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K021462 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K010330 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K961358 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K000729 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K060309 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K970689 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K040801 | ARROW INTL., INC. |
9 PLYMOUTH ST. | EVERETT | MA | 02149 |
| K983866 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K982538 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K972113 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K974247 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K971673 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K963187 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K954431 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K981660 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K973962 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K980850 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01831 |
| K962177 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K112372 | CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC |
1300 MACARTHUR BLVD. | MAHWAH | NJ | 07430 |
| K112327 | CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC |
1300 MACARTHUR BLVD | MAHWAH | NJ | 07430 |
| K163542 | Datascope Corp. |
1300 MacArthur Blvd. | Mahwah | NJ | 07430 |
| K151254 | DATASCOPE CORP. |
1300 MACARTHUR BLVD | MAHWAH | NJ | 07430 |
| K181122 | Datascope Corp. |
1300 MacArthur Blvd. | Mahwah | NJ | 07430 |
| K031636 | DATASCOPE CORP. |
800 MACARTHUR BLVD. | MAHWAH | NJ | 07430-0619 |
| K172305 | Datascope Corp. |
1300 MacArthur Blvd. | Mahwah | NJ | 07430 |
| K041281 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K980385 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K031569 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K063525 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-0011 |
| K964987 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K980780 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K003598 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K020257 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K994157 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K961509 | DATASCOPE CORP. |
580 WINTERS AVE. | PARAMUS | NJ | 07653 |
| K133074 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K002949 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K013326 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K960166 | DATASCOPE CORP. |
15 LAW DR. | FAIRFIELD | NJ | 07004-3206 |
| K965236 | DATASCOPE CORP. |
580 WINTERS AVE. | PARAMUS | NJ | 07652 |
| K091449 | DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. | FAIRFIELD | NJ | 07004-0011 |
| K120868 | DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. | FAIRFIELD | NJ | 07004-0011 |
| K122628 | DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. | FAIRFIELD | NJ | 07004-0011 |
| K082746 | INSIGHTRA MEDICAL, INC. |
15560-C ROCKFIELD BLVD. | IRVINE | CA | 92618 |
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