Cleared Traditional

K964373 - SARNS ARTERIAL CANNULAE WITH DURAFLO TR...

K964373 is an FDA 510(k) clearance for SARNS ARTERIAL CANNULAE WITH DURAFLO TR..., manufactured by 3M Healthcare. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K964373 · 3M Healthcare · Cardiovascular device
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Jun 1997
Decision
229d
Days
Class 2
Risk

K964373 is an FDA 510(k) clearance for the SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by 3M Healthcare (Ann Arbor, US). The FDA issued a Cleared decision on June 18, 1997 after a review of 229 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.

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FDA 510(k) Submission Details - K964373

510(k) Number K964373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date June 18, 1997
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
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 287
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K964373.
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