K080007 is an FDA 510(k) clearance for the GRADUATED ADAPTER WITH CLAVE, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 13, 2008, 132 days after receiving the submission on January 2, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K080007 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 02, 2008 |
| Decision Date | May 13, 2008 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| 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 |