Cleared Traditional

K813037 - FLOWGUARD CATHETERS & CANNALAE

K813037 is the FDA 510(k) clearance for FLOWGUARD CATHETERS & CANNALAE by Advocacy International, Ltd.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K813037 · Advocacy International, Ltd. · Cardiovascular device
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Dec 1981
Decision
47d
Days
Class 2
Risk

K813037 is an FDA 510(k) clearance for the FLOWGUARD CATHETERS & CANNALAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Advocacy International, Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 47 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 Advocacy International, Ltd. devices

Submission Details

510(k) Number K813037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date December 14, 1981
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K813037.
KONTRON LITWAK-KOFFSKY OBTURATED CANNU
K821316 · Kontron Instruments, Inc. · Aug 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · Sherwood Medical Co. · Jul 1982
SUBMISSION CORONARY CANNULA
K821149 · Dlp, Inc. · May 1982
CARDIOPULMONARY BYPASS
K810820 · Dlp, Inc. · Apr 1981
SARNS TWO-STATE WIRE REINFORCED CATHETER
K810415 · 3M Health Care, Sarns · Mar 1981
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · Dlp, Inc. · Mar 1981