MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
FDA 510(k) clearance K803086 · decided 1981-07-01
Clearance details
- K-number
- K803086
- Device name
- MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
- Applicant
- Craig & Craig, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-08
- Decision date
- 1981-07-01
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223 recall (Z-2991-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |
| Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O recall (Z-2993-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |