K894250 is an FDA 510(k) clearance for the LE PTA CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 7, 1990, 259 days after receiving the submission on June 21, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K894250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1989 |
| Decision Date | March 07, 1990 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |