MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
FDA 510(k) clearance K970341 · decided 1997-04-23
Clearance details
- K-number
- K970341
- Device name
- MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
- Applicant
- Medtronic PS Medical
- Decision
- Substantially Equivalent
- Date received
- 1997-01-29
- Decision date
- 1997-04-23
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LIS
- Advisory committee
- Unknown
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.