Cleared Traditional

K882230 - A PORT IMPLANT VASCULAR ACCESS SYSTEM -...

K882230 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 63-day FDA review.

K882230 · Therex Corp. · General Hospital
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Jul 1988
Decision
63d
Days
Class 2
Risk

K882230 is an FDA 510(k) clearance for the A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED. 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 July 29, 1988 after a review of 63 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 - K882230

510(k) Number K882230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1988
Decision Date July 29, 1988
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K882230.
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 .6MM/2.29MM
K893460 · Therex Corp. · Jun 1989
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
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · Pharmacia Deltec, Inc. · Apr 1988