Cleared Traditional

K832475 - AXIOM PERFUSSION CANNULA

K832475 is an FDA 510(k) clearance for AXIOM PERFUSSION CANNULA, manufactured by Axiom Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K832475 · Axiom Medical, Inc. · Cardiovascular device
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Oct 1983
Decision
85d
Days
Class 2
Risk

K832475 is an FDA 510(k) clearance for the AXIOM PERFUSSION CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 85 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K832475

510(k) Number K832475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date October 19, 1983
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K832475.
ARTERIAL CANNULA CURVED BEVELED TIP
K840002 · Dlp, Inc. · Feb 1984
SARNS CARDIOPLEGIA CANNULA Y
K834025 · 3M Health Care, Sarns · Jan 1984
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · Dlp, Inc. · Jan 1984
UNIVERSAL CORONARY CANNULA
K831330 · Possis Medical, Inc. · Aug 1983
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · Sherwood Medical Co. · Jun 1983
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · Dlp, Inc. · Jun 1983