Cleared Traditional

K953945 - RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET

K953945 is an FDA 510(k) clearance for RETROGRADE CORONARY SINUS PERFUSION CAN..., manufactured by Dlp, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K953945 · Dlp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
218d
Days
Class 2
Risk

K953945 is an FDA 510(k) clearance for the RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & I.... Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 26, 1996 after a review of 218 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 Dlp, Inc. devices

FDA 510(k) Submission Details - K953945

510(k) Number K953945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1995
Decision Date March 26, 1996
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K953945.
HEARTPORT ENDOPULMONARY VENT
K961245 · Heartport, Inc. · Jun 1996
HEARTPORT ENDOSINUS CATHETER
K961270 · Heartport, Inc. · Jun 1996
HEARTPORT ENDOARTERIAL RETURN CANNUAL
K955121 · Heartport, Inc. · May 1996
FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
K955818 · Quest Medical, 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