Cleared Traditional

K955818 - FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER

K955818 is the FDA 510(k) clearance for FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER by Quest Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955818 · Quest Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
91d
Days
Class 2
Risk

K955818 is an FDA 510(k) clearance for the FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER. 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 March 26, 1996 after a review of 91 days - within the typical 510(k) review window.

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 Quest Medical, Inc. devices

Submission Details

510(k) Number K955818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 26, 1996
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 229
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K955818.
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · Sorin Group Italia S.R.L. · Aug 1997
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · Research Medical, Inc. · Aug 1996
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
K953945 · Dlp, Inc. · Mar 1996
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
K951088 · Quest Medical, Inc. · Jun 1995
AORTIC ARCH CANNULAS
K943934 · Sorin Group Italia S.R.L. · Jun 1995
QUEST ANTEGRADE CARDIOPLEGIA CANNULA
K950814 · Quest Medical, Inc. · May 1995