Submission Details
| 510(k) Number | K081515 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 30, 2008 |
| Decision Date | July 21, 2008 |
| Days to Decision | 52 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
Jul 2008
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K081515 is an FDA 510(k) clearance for the NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on July 21, 2008, 52 days after receiving the submission on May 30, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| Product Code | FOS — Catheter, Umbilical Artery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
Manufacturer
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