Cleared Traditional

K834134 - SARNS 8.0 SOFT ARC CANNULA

K834134 is an FDA 510(k) clearance for SARNS 8.0 SOFT ARC 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 139-day FDA review.

K834134 · 3M Health Care, Sarns · Cardiovascular device
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Apr 1984
Decision
139d
Days
Class 2
Risk

K834134 is an FDA 510(k) clearance for the SARNS 8.0 SOFT ARC CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 139 days - within the typical 510(k) review window.

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 - K834134

510(k) Number K834134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1983
Decision Date April 17, 1984
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K834134.
ARGYLE CUSTOM TUBING PACK
K842889 · Sherwood Medical Co. · Aug 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · Dlp, Inc. · Aug 1984
PRESSURE CATHETER PLACEMENT SET 50010
K841482 · Dlp, Inc. · Jun 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · Sherwood Medical Co. · Apr 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · Shiley, Inc. · Apr 1984
ARTERIAL CANNULA STRAIGHT BEVELED TIP
K840001 · Dlp, Inc. · Feb 1984