K902370 is an FDA 510(k) clearance for the MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER. This device is classified as a Dilator, Urethral, Mechanical (Class II - Special Controls, product code FAH).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 17, 1990, 80 days after receiving the submission on May 29, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K902370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1990 |
| Decision Date | August 17, 1990 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAH — Dilator, Urethral, Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5520 |