Cleared Traditional

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 (K974475) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974475 · Biocontrol Technology, Inc. · General Hospital
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Mar 1998
Decision
96d
Days
Class 2
Risk

K974475 is an FDA 510(k) clearance for the THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Biocontrol Technology, Inc. (Indiana, US). The FDA issued a Cleared decision on March 2, 1998 after a review of 96 days - within the typical 510(k) review window.

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 Biocontrol Technology, Inc. devices

Submission Details

510(k) Number K974475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date March 02, 1998
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
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 47
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K974475.
VAXCEL WITH PASV PORT
K030083 · Boston Scientific Corp · Jan 2003
BARDPORT X-PORT ISP PORT
K022983 · C.R. Bard, Inc. · Sep 2002
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
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · B.Braun Medical, Inc. · Dec 1996