Cleared Traditional

K915193 - SARNS RETROGRADE CANNULA

K915193 is an FDA 510(k) clearance for SARNS RETROGRADE CANNULA, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K915193 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
106d
Days
Class 2
Risk

K915193 is an FDA 510(k) clearance for the SARNS RETROGRADE CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 106 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K915193

510(k) Number K915193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date March 04, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 269
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K915193.
SARNS RETROGRADE CANNULA - AUTO INFLATE
K922471 · 3M Health Care, Sarns · Mar 1993
CONDUCER CARDIOPLEGIA SET SITH MP4
K922992 · 3M Health Care, Ltd. · Sep 1992
CATHETER TWO STAGE VENOUS RETURN
K915268 · Dlp, Inc. · Jul 1992
CARDIOPULMONARY BYPASS VASCULAR CATHETER
K905224 · 3M Health Care, Sarns · Feb 1991
SARNS INVENT CATHETERS
K905638 · 3M Health Care, Sarns · Feb 1991
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · Fresenius USA, Inc. · Sep 1990