The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix Catheter And Contiplex Catheter.
Device ID | K042488 |
510k Number | K042488 |
Device Name: | PERIFIX CATHETER AND CONTIPLEX CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Amy Smith |
Correspondent | Amy Smith B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-13 |
Decision Date | 2004-09-30 |
Summary: | summary |