K972964 is an FDA 510(k) clearance for the ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE. This device is classified as a Dilator, Urethral (Class II - Special Controls, product code KOE).
Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on October 10, 1997, 60 days after receiving the submission on August 11, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K972964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1997 |
| Decision Date | October 10, 1997 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOE — Dilator, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5520 |