Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 1978 | K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc. | DYB |
| Nov 2, 1977 | K771982 | 888 ARTERIAL/VENOUS CATHETER INTRODUCER Usci, Div. C.R. Bard, Inc. | DYB |
| Jul 13, 1977 | K771042 | INTRODUCER, CAT. #INT-05FR. Sorensen Research | DYB |
| Jul 13, 1977 | K771041 | INTRODUCER, CAT. #INT-06FR. Sorensen Research | DYB |
| Jun 29, 1977 | K771040 | INTRODUCER, CAT. #INT-07FR. Sorensen Research | DYB |
| Apr 26, 1977 | K770561 | CATHETER,PERCUTANEOUS INTRODUC. & SHEATH Usci, Div. C.R. Bard, Inc. | DYB |
| Mar 16, 1977 | K770427 | CATHETER INTRODUCER KIT Electro-Catheter Corp. | DYB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.