CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
FDA 510(k) clearance K892530 · decided 1989-09-26
Clearance details
- K-number
- K892530
- Device name
- CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-11
- Decision date
- 1989-09-26
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- DYG
- Device class
- 2
- Regulation number
- 870.1240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographi recall (Z-1057-2013) | Arrow International Inc | 2013-04-04 |