510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945551Substantially Equivalent

Celsite(tm) Dual Venous System

B. Braun of America, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945551 is the FDA 510(k) clearance record for CELSITE(TM) DUAL VENOUS SYSTEM, a class II device, cleared for B. Braun of America, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 19 510(k) clearances for B. Braun of America, Inc., from to . As of , FDA records show no recalls naming K945551.

Clearance record

Decision date
Received
(158 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
B. Braun of America, Inc. 824 Twelfth Ave., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260