K965251 is an FDA 510(k) clearance for the MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM. This device is classified as a Catheter, Percutaneous, Intraspinal, Short Term (Class II - Special Controls, product code MAJ).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on March 18, 1997, 89 days after receiving the submission on December 19, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K965251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1996 |
| Decision Date | March 18, 1997 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MAJ — Catheter, Percutaneous, Intraspinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |