Cleared Special

K031398 - IS-1 HEMOSTASIS VALVE, MODEL 6799

K031398 is an FDA 510(k) clearance for IS-1 HEMOSTASIS VALVE, manufactured by Guidant Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Special 510(k) pathway after a 15-day FDA review.

K031398 · Guidant Corp. · Cardiovascular device
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May 2003
Decision
15d
Days
Class 2
Risk

K031398 is an FDA 510(k) clearance for the IS-1 HEMOSTASIS VALVE, MODEL 6799. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Guidant Corp. (St Paul, US). The FDA issued a Cleared decision on May 20, 2003 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031398

510(k) Number K031398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date May 20, 2003
Days to Decision 15 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 136
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K031398.
MYSHELL
K040498 · Sedat S.A. · Jul 2004
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K033328 · Novosci Corp. · Jan 2004
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688 · Guidant Corporation · Jul 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · Gish Biomedical, Inc. · Mar 2003
ADAPTERS WITH X-COATING
K022918 · Terumo Cardiovascular Systems Corporation · Nov 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282 · Guidant Corp. · May 2002
K031398 · IS-1 HEMOSTASIS VALVE, MODEL 6799
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