K091306 is an FDA 510(k) clearance for the AMSURE PVC INTERMITTENT CATHETER. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on August 21, 2009, 109 days after receiving the submission on May 4, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K091306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2009 |
| Decision Date | August 21, 2009 |
| Days to Decision | 109 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |