Cleared Traditional

K873212 - SARNS CARDIOPLEGIA/VENT CATHETERS

K873212 is an FDA 510(k) clearance for SARNS CARDIOPLEGIA/VENT CATHETERS, 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 84-day FDA review.

K873212 · 3M Health Care, Sarns · Cardiovascular device
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Nov 1987
Decision
84d
Days
Class 2
Risk

K873212 is an FDA 510(k) clearance for the SARNS CARDIOPLEGIA/VENT CATHETERS. 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 November 6, 1987 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K873212

510(k) Number K873212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date November 06, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K873212.
SARNS VENOATRIAL CATHETER
K875048 · 3M Health Care, Sarns · Feb 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · 3M Health Care, Sarns · Feb 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988
CHURCHILL INTER-CARDIAC SUCKER
K872043 · Churchill Corp. · Sep 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · Uresil Corp. · Sep 1987
TORAY ANTHRON AORTA BYPASS TUBES
K872762 · Toray Industries (America), Inc. · Sep 1987