Cleared Traditional

K921475 - A-PORT IMPLANT VASCULAR ACCESS SYST CAT...

K921475 is an FDA 510(k) clearance for A-PORT IMPLANT VASCULAR ACCESS SYST CAT..., manufactured by Therex Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K921475 · Therex Corp. · General Hospital
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Oct 1992
Decision
200d
Days
Class 2
Risk

K921475 is an FDA 510(k) clearance for the A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Therex Corp. (Walpole, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 200 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 Therex Corp. devices

FDA 510(k) Submission Details - K921475

510(k) Number K921475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date October 16, 1992
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K921475.
IPI IMPORT
K922419 · Pudenz-Schulte Medical Research Corp. · Nov 1992
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K921379 · Therex Corp. · Nov 1992
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K922434 · Therex Corp. · Nov 1992
VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.
K921201 · Med Institute, Inc. · Jul 1992
PLASTIC ATTACHABLE DUAL PORT
K912702 · Davol, Inc. · Sep 1991
VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM
K913350 · Med Institute, Inc. · Aug 1991