Cleared Traditional

K873971 - ROTATING HEMOSTATIC VALVE

K873971 is an FDA 510(k) clearance for ROTATING HEMOSTATIC VALVE, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K873971 · Target Therapeutics · Cardiovascular device
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Jan 1988
Decision
112d
Days
Class 2
Risk

K873971 is an FDA 510(k) clearance for the ROTATING HEMOSTATIC VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Target Therapeutics devices

FDA 510(k) Submission Details - K873971

510(k) Number K873971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1987
Decision Date January 19, 1988
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 103
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K873971.
LIPID STOPCOCK
K890580 · North American Instrument Corp. · Apr 1989
NAMIC DUAL BACKCHECK VALVE
K884408 · North American Instrument Corp. · Jan 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988
SILENT GUARD CAT. NO. SG-10
K873488 · American Omni Medical, Inc. · Oct 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · Shiley, Inc. · Aug 1987
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986