Cleared Traditional

K896598 - STRATO INDWELLING CATHETER

K896598 is the FDA 510(k) clearance for STRATO INDWELLING CATHETER by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K896598 · Strato Medical Corp. · General Hospital
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Apr 1990
Decision
155d
Days
Class 2
Risk

K896598 is an FDA 510(k) clearance for the STRATO INDWELLING CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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

Submission Details

510(k) Number K896598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date April 25, 1990
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 186
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K896598.
VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
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WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
K895543 · Strato Medical Corp. · Sep 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168 · Vygon Corp. · Apr 1990
PERCUTANEOUS INTRAVENOUS CATHETERS
K895712 · Pharmacia Deltec, Inc. · Dec 1989
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989