K951448 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Global Medical Products, Ltd. (Road Town, Tortola, VG). The FDA issued a Cleared decision on March 27, 1996, 364 days after receiving the submission on March 29, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K951448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1995 |
| Decision Date | March 27, 1996 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |