K901018 is an FDA 510(k) clearance for the MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on May 30, 1990, 86 days after receiving the submission on March 5, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K901018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1990 |
| Decision Date | May 30, 1990 |
| Days to Decision | 86 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 |