Panels › Cardiovascular › Product code DSA · Class 2
Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation 870.2900
2510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
6recalls that name a 510(k)
Top companies in DSA
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare, LLC | 0 | 5 |
| Medtronic Vascular | 5 | 0 |
| Remington Medical, Inc. | 2 | 2 |
| Tronomed, Inc. | 4 | 0 |
| Arbo Medical, Inc. | 3 | 0 |
| Vyaire Medical, Inc. | 3 | 0 |
| Baylis Medical Technologies, Inc. | 2 | 0 |
| Beijing Rongrui-Century Science & Technology Co., Ltd. | 2 | 0 |
| Biosense Webster, Inc. | 1 | 1 |
| Boston Scientific | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 1980 | K801064 | DISPOSABLE PATIENT CABLE MODEL 5807 Daig Corp. | DSA |
| Oct 18, 1977 | K771645 | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE Tronomed, Inc. | DSA |
| Sep 30, 1977 | K771750 | RF CHOKE CABLE C.R. Bard, Inc. | DSA |
| Jul 5, 1977 | K771027 | ELECTROCARDIOGRAPHIC PATIENT CABLES Tronomed, Inc. | DSA |
| May 23, 1977 | K770884 | ELHCTROCARDIOGRAPHIC CONNECTING WIRES Tronomed, Inc. | DSA |
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