Cleared Traditional

K925442 - SARNS RETROGRADE CANNULA

K925442 is an FDA 510(k) clearance for SARNS RETROGRADE CANNULA, 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 205-day FDA review.

K925442 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
205d
Days
Class 2
Risk

K925442 is an FDA 510(k) clearance for the SARNS RETROGRADE 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 21, 1993 after a review of 205 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.

View all 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K925442

510(k) Number K925442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date May 21, 1993
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K925442.
EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM
K932208 · Baxter Healthcare Corp · Aug 1994
SARNS LOW JETTING AORTIC ARCH CANNULA
K934127 · 3M Health Care, Sarns · Feb 1994
QUEST HEART INSULATION PAD
K925049 · Quest Medical, Inc. · Feb 1994
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
K920902 · 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