Cleared Traditional

K905528 - URESIL VALVE CUTTER

K905528 is an FDA 510(k) clearance for URESIL VALVE CUTTER, manufactured by Uresil Corp.. The device is a Class 2 Cardiovascular device with product code DWQ cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K905528 · Uresil Corp. · Cardiovascular device
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Apr 1991
Decision
129d
Days
Class 2
Risk

K905528 is an FDA 510(k) clearance for the URESIL VALVE CUTTER. Classified as Stripper, Vein, External (product code DWQ), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on April 18, 1991 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Uresil Corp. devices

FDA 510(k) Submission Details - K905528

510(k) Number K905528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1990
Decision Date April 18, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWQ Device Classification - Class 2, Special Controls

Product Code DWQ Stripper, Vein, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
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 - DWQ Stripper, Vein, External

Devices cleared under the same product code (DWQ) and FDA review panel - the closest regulatory comparables to K905528.
PhasTIPP
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PILLING BRUSH VALVULOTOME
K904507 · Pilling Co. · Mar 1991
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K811910 · Atrium Medical Corp. · Jul 1981