Cleared Traditional

K900753 - SHILEY VEIN IRRIGATION CANNULA (BEVELED...

K900753 is an FDA 510(k) clearance for SHILEY VEIN IRRIGATION CANNULA (BEVELED..., manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K900753 · Shiley, Inc. · Cardiovascular device
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Apr 1990
Decision
53d
Days
Class 2
Risk

K900753 is an FDA 510(k) clearance for the SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT). Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 53 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K900753

510(k) Number K900753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date April 10, 1990
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K900753.
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · Dlp, Inc. · Jul 1990
RMI CARDIOPLEGIA DELIVERY KITS
K901231 · Research Medical, Inc. · Jun 1990
PICSO CANNULA, CATALOG CODE 94315
K897022 · Dlp, Inc. · Mar 1990
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · Research Medical, Inc. · Feb 1990
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
K896778 · Research Medical, Inc. · Feb 1990