Cleared Traditional

K861641 - HEPARIN-COATED EXTRACORPOREAL CIRCUITS

K861641 is the FDA 510(k) clearance for HEPARIN-COATED EXTRACORPOREAL CIRCUITS by American Bentley. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K861641 · American Bentley · Cardiovascular device
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Sep 1986
Decision
152d
Days
Class 2
Risk

K861641 is an FDA 510(k) clearance for the HEPARIN-COATED EXTRACORPOREAL CIRCUITS. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 American Bentley devices

Submission Details

510(k) Number K861641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date September 29, 1986
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 123
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K861641.
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
K864235 · C.R. Bard, Inc. · Jan 1987
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · Scimed Life Systems, Inc. · Nov 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · 3M Health Care, Sarns · Nov 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · Scimed Life Systems, Inc. · Sep 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · Terumo Medical Corp. · May 1986
SARNS OXYGENATOR SYSTEM
K860539 · 3M Health Care, Sarns · Apr 1986