Cleared Traditional

K875048 - SARNS VENOATRIAL CATHETER

K875048 is the FDA 510(k) clearance for SARNS VENOATRIAL CATHETER by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K875048 · 3M Health Care, Sarns · Cardiovascular device
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Feb 1988
Decision
71d
Days
Class 2
Risk

K875048 is an FDA 510(k) clearance for the SARNS VENOATRIAL CATHETER. 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 February 18, 1988 after a review of 71 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

Submission Details

510(k) Number K875048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date February 18, 1988
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 253
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K875048.
DESCENDING ARCH CANNULA
K880421 · Dlp, Inc. · Apr 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · Dlp, Inc. · Mar 1988
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.
K880103 · Research Medical, Inc. · Mar 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · 3M Health Care, Sarns · Feb 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · 3M Health Care, Sarns · Nov 1987