ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
FDA 510(k) clearance K960479 · decided 1996-10-17
Clearance details
- K-number
- K960479
- Device name
- ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-02
- Decision date
- 1996-10-17
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- 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 |
|---|---|---|
| Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU recall (Z-2383-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| Arrow Balloon and stylet temporary pacing catheter recall (Z-1500-2009) | Arrow International Inc | 2009-06-24 |
| Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF801591 recall (Z-1907-2008) | Arrow International Inc | 2008-09-16 |
| Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number RF801592 recall (Z-1908-2008) | Arrow International Inc | 2008-09-16 |