TECHDEVICE OCCLUSION BALLOON CATHETER
FDA 510(k) clearance K051137 · decided 2006-02-24
Clearance details
- K-number
- K051137
- Device name
- TECHDEVICE OCCLUSION BALLOON CATHETER
- Applicant
- Techdevice Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-05-04
- Decision date
- 2006-02-24
- Days to decision
- 296 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartS recall (Z-0322-2011) | Philips Healthcare Inc. | 2010-11-08 |