Cleared Traditional

K962230 - CELSITE PORT WITH PRECONNECTED CATHETER

K962230 is the FDA 510(k) clearance for CELSITE PORT WITH PRECONNECTED CATHETER 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 189-day FDA review.

K962230 · B.Braun Medical, Inc. · General Hospital
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Dec 1996
Decision
189d
Days
Class 2
Risk

K962230 is an FDA 510(k) clearance for the CELSITE PORT WITH PRECONNECTED CATHETER. 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 16, 1996 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K962230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date December 16, 1996
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 K962230.
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · Boston Scientific Corp · Oct 1998
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · Boston Scientific Corp · Mar 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · C.R. Bard, Inc. · Mar 1997
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684 · Arrow Intl., Inc. · Oct 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615 · Arrow Intl., Inc. · Jul 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · Arrow Intl., Inc. · Jul 1996