K991977 is an FDA 510(k) clearance for the TYSHAK, MODEL 102 AND Z-MED, MODEL 302. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on September 27, 2000, 474 days after receiving the submission on June 11, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K991977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1999 |
| Decision Date | September 27, 2000 |
| Days to Decision | 474 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |