K961438 is an FDA 510(k) clearance for the BALLON DILATATION CATHETER. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 31, 1996, 107 days after receiving the submission on April 15, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K961438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1996 |
| Decision Date | July 31, 1996 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |