The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Pediatric Central Venous Catheter Kit.
Device ID | K023253 |
510k Number | K023253 |
Device Name: | PEDIATRIC CENTRAL VENOUS CATHETER KIT |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Patricia D Wilson |
Correspondent | Patricia D Wilson B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2002-09-30 |
Decision Date | 2003-05-06 |
Summary: | summary |