K112636 is an FDA 510(k) clearance for the CYTOGUARD(TM) CLOSED LUER CONNECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 26, 2011, 78 days after receiving the submission on September 9, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K112636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2011 |
| Decision Date | November 26, 2011 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |