Cleared Traditional

K920902 - MODIFICATION OF SARNS TWO STAGE VENOUS ...

K920902 is an FDA 510(k) clearance for MODIFICATION OF SARNS TWO STAGE VENOUS ..., 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 440-day FDA review.

K920902 · 3M Health Care, Sarns · Cardiovascular device
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May 1993
Decision
440d
Days
Class 2
Risk

K920902 is an FDA 510(k) clearance for the MODIFICATION OF SARNS TWO STAGE VENOUS 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 May 11, 1993 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K920902

510(k) Number K920902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date May 11, 1993
Days to Decision 440 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 125d · This submission: 440d
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 K920902.
SARNS LOW JETTING AORTIC ARCH CANNULA
K934127 · 3M Health Care, Sarns · Feb 1994
QUEST HEART INSULATION PAD
K925049 · Quest Medical, Inc. · Feb 1994
SARNS RETROGRADE CANNULA
K925442 · 3M Health Care, Sarns · May 1993
BARD WILLIAM HARVEY TWO STAGE CANNULA
K930684 · C.R. Bard, Inc. · May 1993
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA
K930620 · C.R. Bard, Inc. · May 1993
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
K930593 · C.R. Bard, Inc. · May 1993