K961336 is an FDA 510(k) clearance for the MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on July 18, 1996, 101 days after receiving the submission on April 8, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K961336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1996 |
| Decision Date | July 18, 1996 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |