Cleared Traditional

K810415 - SARNS TWO-STATE WIRE REINFORCED CATHETER

K810415 is the FDA 510(k) clearance for SARNS TWO-STATE WIRE REINFORCED CATHETER by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K810415 · 3M Health Care, Sarns · Cardiovascular device
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Mar 1981
Decision
27d
Days
Class 2
Risk

K810415 is an FDA 510(k) clearance for the SARNS TWO-STATE WIRE REINFORCED CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 27 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

Submission Details

510(k) Number K810415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 17, 1981
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 253
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K810415.
SUBMISSION CORONARY CANNULA
K821149 · Dlp, Inc. · May 1982
DISPOSABLE 2-STAGE CANNULA
K810515 · Texas Medical Products, Inc. · Apr 1981
CARDIOPULMONARY BYPASS
K810820 · Dlp, Inc. · Apr 1981
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · Dlp, Inc. · Mar 1981
RIDGID VENA CAVA CANNULAE
K802543 · Texas Medical Products, Inc. · Jan 1981
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · Bentley Laboratories, Inc. · Oct 1980