K942154 is an FDA 510(k) clearance for the SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 18, 1994, 125 days after receiving the submission on April 15, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K942154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1994 |
| Decision Date | August 18, 1994 |
| Days to Decision | 125 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 |