K031748 is an FDA 510(k) clearance for the VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES. This device is classified as a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL).
Submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on August 27, 2003, 83 days after receiving the submission on June 5, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K031748 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2003 |
| Decision Date | August 27, 2003 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |