The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Cytoguard(tm) Closed Luer Connector.
| Device ID | K112636 |
| 510k Number | K112636 |
| Device Name: | CYTOGUARD(TM) CLOSED LUER CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2011-11-26 |
| Summary: | summary |