K952887 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER. This device is classified as a Catheter, Nephrostomy.
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on August 18, 1995, 56 days after receiving the submission on June 23, 1995.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K952887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1995 |
| Decision Date | August 18, 1995 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |