K963595 is an FDA 510(k) clearance for the SERAGARD VASCULAR ACCESS DEVICE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Cutting Edge Technologies, Inc. (West Chester, US). The FDA issued a Cleared decision on January 6, 1997, 119 days after receiving the submission on September 9, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K963595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1996 |
| Decision Date | January 06, 1997 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |