Cleared Traditional

K893460 - A-PORT IMPLANT VASCULAR ACCESS SYSTEM ....

K893460 is an FDA 510(k) clearance for A-PORT IMPLANT VASCULAR ACCESS SYSTEM ...., 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 51-day FDA review.

K893460 · Therex Corp. · General Hospital
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Jun 1989
Decision
51d
Days
Class 2
Risk

K893460 is an FDA 510(k) clearance for the A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM. 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 June 23, 1989 after a review of 51 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 Therex Corp. devices

FDA 510(k) Submission Details - K893460

510(k) Number K893460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1989
Decision Date June 23, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 K893460.
LIFEPORT VASCULAR ACCESS PORT
K895689 · Strato Medical Corp. · Dec 1989
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
K896093 · Therex Corp. · Dec 1989
LIFEPORT POLYURETHANE CATHETER
K895871 · Strato Medical Corp. · Nov 1989
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
K882230 · Therex Corp. · Jul 1988
LIFEPORT II, MODEL LPS-1100
K881075 · Strato Medical Corp. · Jun 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
K880305 · Strato Medical Corp. · Apr 1988