K953597 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on October 7, 1995, 67 days after receiving the submission on August 1, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K953597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1995 |
| Decision Date | October 07, 1995 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZN — Dilator, Catheter, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5470 |