K924320 is an FDA 510(k) clearance for the ULTRA THIN BALLOON DILATATION CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 10, 1993, 440 days after receiving the submission on August 27, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K924320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1992 |
| Decision Date | November 10, 1993 |
| Days to Decision | 440 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 |