510(k) K051137 ยท MJN Catheter, Intravascular Occluding, Temporary
TECHDEVICE OCCLUSION BALLOON CATHETER
| Applicant | Techdevice Corporation, Watertown MA, US |
| Decision | Substantially Equivalent, Feb 24, 2006 |
| Received | May 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator/Monitor
Models: M3535A / M3536A / M3536J / M3536MC
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.