Cleared Traditional

K905638 - SARNS INVENT CATHETERS

K905638 is an FDA 510(k) clearance for SARNS INVENT 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 45-day FDA review.

K905638 · 3M Health Care, Sarns · Cardiovascular device
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Feb 1991
Decision
45d
Days
Class 2
Risk

K905638 is an FDA 510(k) clearance for the SARNS INVENT 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 February 1, 1991 after a review of 45 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 - K905638

510(k) Number K905638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date February 01, 1991
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K905638.
CATHETER TWO STAGE VENOUS RETURN
K915268 · Dlp, Inc. · Jul 1992
SARNS RETROGRADE CANNULA
K915193 · 3M Health Care, Sarns · Mar 1992
CARDIOPULMONARY BYPASS VASCULAR CATHETER
K905224 · 3M Health Care, Sarns · Feb 1991
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · Fresenius USA, Inc. · Sep 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · Dlp, Inc. · Jul 1990