Cleared Traditional

K890024 - SARNS VENT CATHETER

K890024 is the FDA 510(k) clearance for SARNS VENT CATHETER by 3M Company. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K890024 · 3M Company · Cardiovascular device
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Mar 1989
Decision
57d
Days
Class 2
Risk

K890024 is an FDA 510(k) clearance for the SARNS VENT CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on March 2, 1989 after a review of 57 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 Company devices

Submission Details

510(k) Number K890024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date March 02, 1989
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 229
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K890024.
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1989
FEM-FLEX FEMORAL ACCESS CANNULATION SET
K891576 · Research Medical, Inc. · Oct 1989
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · Shiley, Inc. · May 1989
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · Quinton, Inc. · Feb 1989
ANGIOPUMP TUBING SET
K884310 · Olympus Corp. · Jan 1989
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · Shiley, Inc. · Dec 1988