K042504 is an FDA 510(k) clearance for the CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on January 19, 2006, 491 days after receiving the submission on September 15, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K042504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2004 |
| Decision Date | January 19, 2006 |
| Days to Decision | 491 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |