Cleared Traditional

K924529 - SIGNATURE(TM) CUSTOM TUBING PACK

K924529 is an FDA 510(k) clearance for SIGNATURE(TM) CUSTOM TUBING PACK, manufactured by Avecor Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K924529 · Avecor Cardiovascular, Inc. · Cardiovascular device
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Jun 1993
Decision
288d
Days
Class 2
Risk

K924529 is an FDA 510(k) clearance for the SIGNATURE(TM) CUSTOM TUBING PACK. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Avecor Cardiovascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 23, 1993 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Avecor Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K924529

510(k) Number K924529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 08, 1992
Decision Date June 23, 1993
Days to Decision 288 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 125d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 317
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