Cleared Traditional

POLYCATH #WMC-900 (K912270) - FDA 510(k) Clearance

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

K912270 · Worldwide Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
441d
Days
Class 2
Risk

K912270 is an FDA 510(k) clearance for the POLYCATH #WMC-900. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Worldwide Medical (Sunrise, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 441 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 Worldwide Medical devices

Submission Details

510(k) Number K912270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1991
Decision Date August 05, 1992
Days to Decision 441 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 125d · This submission: 441d
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 154
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K912270.
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310 · Cordis Corp. · Sep 1992
LUKENS 2-0 BRAIDED SILK SUTURES
K922254 · Quinton, Inc. · Sep 1992
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980 · C.R. Bard, Inc. · Aug 1992
CARDIAC CATHERIZATION KIT
K914299 · Abbott Laboratories · Jun 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498 · Cordis Corp. · Apr 1992
DESERET GUIDEWIRE INTRODUCER II
K920407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992