K933020 is an FDA 510(k) clearance for the MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER. This device is classified as a Catheter, Ureteral, Gastro-urology (Class II - Special Controls, product code EYB).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on January 3, 1994, 195 days after receiving the submission on June 22, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K933020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |