CELSITE PEDIATRIC VENOUS SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intravascular

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Celsite Pediatric Venous System.

Pre-market Notification Details

• Device ID: K952435
• 510k Number: K952435
• Device Name: CELSITE PEDIATRIC VENOUS SYSTEM
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: B. BRAUN MEDICAL, INC. POSTFACH 110 CARL BRAUN STR 1 D-3508 Melsungen, DE
• Contact: Mark S Alsbbrge
• Correspondent: Mark S Alsbbrge; B. BRAUN MEDICAL, INC. POSTFACH 110 CARL BRAUN STR 1 D-3508 Melsungen, DE
• Product Code: LJT
• CFR Regulation Number: 880.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-24
• Decision Date: 1996-04-17
• Summary: summary