Cleared Traditional

K862190 - WALRUS: DOUBLE BALLOON SHUNTING CATHETER

K862190 is the FDA 510(k) clearance for WALRUS: DOUBLE BALLOON SHUNTING CATHETER by Medical Parameters, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K862190 · Medical Parameters, Inc. · Cardiovascular device
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Nov 1986
Decision
147d
Days
Class 2
Risk

K862190 is an FDA 510(k) clearance for the WALRUS: DOUBLE BALLOON SHUNTING CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medical Parameters, Inc. (Woburn, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Parameters, Inc. devices

Submission Details

510(k) Number K862190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date November 03, 1986
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
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 150
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K862190.
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · 3M Health Care, Sarns · Nov 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987
ARGYLE VASCULAR BYPASS SET
K871844 · Sherwood Medical Co. · Aug 1987
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · Shiley, Inc. · May 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · Gish Biomedical, Inc. · May 1986