The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Ultrasite Valve.
| Device ID | K031923 |
| 510k Number | K031923 |
| Device Name: | ULTRASITE VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884001373 | K031923 | 000 |
| 30849884006194 | K031923 | 000 |