K970341 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT..
Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on April 23, 1997, 84 days after receiving the submission on January 29, 1997.
This device falls under the General Hospital FDA review panel.
| 510(k) Number | K970341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1997 |
| Decision Date | April 23, 1997 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LIS |
| Device Class | — |