Cleared Traditional

K941916 - QUEST CORONARY SINUS PERFUSION CANNULA -FRCC

K941916 is an FDA 510(k) clearance for QUEST CORONARY SINUS PERFUSION CANNULA ..., manufactured by Quest Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K941916 · Quest Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
352d
Days
Class 2
Risk

K941916 is an FDA 510(k) clearance for the QUEST CORONARY SINUS PERFUSION CANNULA -FRCC. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Quest Medical, Inc. devices

FDA 510(k) Submission Details - K941916

510(k) Number K941916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date April 06, 1995
Days to Decision 352 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 125d · This submission: 352d
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 330
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K941916.
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
K951088 · Quest Medical, Inc. · Jun 1995
AORTIC ARCH CANNULAS
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QUEST ANTEGRADE CARDIOPLEGIA CANNULA
K950814 · Quest Medical, Inc. · May 1995
QUEST CORONARY SINUS PERFUSION CANNULA
K941166 · Quest Medical, Inc. · Jan 1995
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K932208 · Baxter Healthcare Corp · Aug 1994
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K934127 · 3M Health Care, Sarns · Feb 1994