Cleared Traditional

K954297 - CELSITE VENOUS ACCESS SYSTEM OTW

K954297 is the FDA 510(k) clearance for CELSITE VENOUS ACCESS SYSTEM OTW by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K954297 · B.Braun Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
78d
Days
Class 2
Risk

K954297 is an FDA 510(k) clearance for the CELSITE VENOUS ACCESS SYSTEM OTW. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K954297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date December 01, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K954297.
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · B.Braun Medical, Inc. · Apr 1996
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
A2 DETACHED DUAL PORT SYSTEM
K955819 · Arrow Intl., Inc. · Mar 1996
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433 · Gish Biomedical, Inc. · Nov 1995
VASPORT VASCULAR ACCESS PORT
K953571 · Gish Biomedical, Inc. · Oct 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953073 · Arrow Intl., Inc. · Sep 1995