Cleared Traditional

K895543 - WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS ...

K895543 is the FDA 510(k) clearance for WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS ... by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K895543 · Strato Medical Corp. · General Hospital
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Sep 1990
Decision
373d
Days
Class 2
Risk

K895543 is an FDA 510(k) clearance for the WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS 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 September 21, 1990 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K895543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1989
Decision Date September 21, 1990
Days to Decision 373 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
244d slower than avg
Panel avg: 129d · This submission: 373d
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 K895543.
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
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VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
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STRATO INDWELLING CATHETER
K896598 · Strato Medical Corp. · Apr 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168 · Vygon Corp. · Apr 1990
PERCUTANEOUS INTRAVENOUS CATHETERS
K895712 · Pharmacia Deltec, Inc. · Dec 1989