Cleared Traditional

K897168 - EPICUTANEO-CAVA CATHETER CODE 2184

K897168 is an FDA 510(k) clearance for EPICUTANEO-CAVA CATHETER CODE 2184, manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K897168 · Vygon Corp. · General Hospital
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Apr 1990
Decision
117d
Days
Class 2
Risk

K897168 is an FDA 510(k) clearance for the EPICUTANEO-CAVA CATHETER CODE 2184. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Vygon Corp. (New York, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 117 days - within the typical 510(k) review window.

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 Vygon Corp. devices

FDA 510(k) Submission Details - K897168

510(k) Number K897168 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 27, 1989
Decision Date April 23, 1990
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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 193
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K897168.
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WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
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STRATO INDWELLING CATHETER
K896598 · Strato Medical Corp. · Apr 1990
PERCUTANEOUS INTRAVENOUS CATHETERS
K895712 · Pharmacia Deltec, Inc. · Dec 1989
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K892926 · Vas-Cath, Inc. · Dec 1989
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K893126 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989