Cleared Traditional

K895689 - LIFEPORT VASCULAR ACCESS PORT

K895689 is an FDA 510(k) clearance for LIFEPORT VASCULAR ACCESS PORT, manufactured by Strato Medical Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K895689 · Strato Medical Corp. · General Hospital
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Dec 1989
Decision
96d
Days
Class 2
Risk

K895689 is an FDA 510(k) clearance for the LIFEPORT VASCULAR ACCESS PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on December 27, 1989 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 Strato Medical Corp. devices

FDA 510(k) Submission Details - K895689

510(k) Number K895689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date December 27, 1989
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
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 238
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K895689.
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691 · Therex Corp. · Oct 1990
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K903220 · Pharmacia Deltec, Inc. · Oct 1990
Q-PORT SYSTEM KIT
K894650 · Quinton, Inc. · Mar 1990
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