Cleared Traditional

K861641 - HEPARIN-COATED EXTRACORPOREAL CIRCUITS

K861641 is an FDA 510(k) clearance for HEPARIN-COATED EXTRACORPOREAL CIRCUITS, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K861641

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
Combination Product No
PCCP Authorized No
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.

DTZ Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K861641.
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · Scimed Life Systems, Inc. · Nov 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · 3M Health Care, Sarns · Nov 1986
OXYGENATOR MODEL NO. BENTLEY-10 PLUS
K863249 · American Bentley · Oct 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · Scimed Life Systems, Inc. · Sep 1986
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
K860673 · American Bentley · Jun 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · Terumo Medical Corp. · May 1986