Cleared Traditional

THERAPORT VASCULAR ACCESS SYSTEM (K960350) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL 1001, 1002, 1601, 1602

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

K960350 · Biocontrol Technology, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
81d
Days
Class 2
Risk

K960350 is an FDA 510(k) clearance for the THERAPORT VASCULAR ACCESS SYSTEM. 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 April 15, 1996 after a review of 81 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 Biocontrol Technology, Inc. devices

Submission Details

510(k) Number K960350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 15, 1996
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K960350.
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
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · B.Braun Medical, Inc. · Apr 1996
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · B.Braun Medical, Inc. · Dec 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · United States Surgical, A Division of Tyco Healthc · Aug 1995