K974788 is an FDA 510(k) clearance for the CRE(TM) BALLOON 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 March 20, 1998, 88 days after receiving the submission on December 22, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K974788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1997 |
| Decision Date | March 20, 1998 |
| Days to Decision | 88 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 |