The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix Catheter Connector.
Device ID | K022019 |
510k Number | K022019 |
Device Name: | PERIFIX CATHETER CONNECTOR |
Classification | Catheter, Conduction, Anesthetic |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
Contact | Amy S Krall |
Correspondent | Amy S Krall B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-20 |
Decision Date | 2002-08-01 |
Summary: | summary |