K952968 is an FDA 510(k) clearance for the DILATATION CATHETER, BALLOON. This device is classified as a Catheter, Nephrostomy.
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on August 10, 1995, 44 days after receiving the submission on June 27, 1995.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K952968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1995 |
| Decision Date | August 10, 1995 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |