K043249 is an FDA 510(k) clearance for the ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on May 25, 2005, 183 days after receiving the submission on November 23, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K043249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2004 |
| Decision Date | May 25, 2005 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |