Cleared Traditional

WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER (K892671) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K892671 · Wilson Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
615d
Days
Class 2
Risk

K892671 is an FDA 510(k) clearance for the WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Wilson Biomedical, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 615 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Wilson Biomedical, Inc. devices

Submission Details

510(k) Number K892671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date December 17, 1990
Days to Decision 615 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
490d slower than avg
Panel avg: 125d · This submission: 615d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K892671.
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · C.R. Bard, Inc. · Feb 1991
MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · C.R. Bard, Inc. · Apr 1990
SONICATH(TM) 5 F
K895542 · Boston Scientific Corp · Apr 1990