Cleared Traditional

K021282 - LV-1 HEMOSTASIS VALVE

K021282 is the FDA 510(k) clearance for LV-1 HEMOSTASIS VALVE by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K021282 · Guidant Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
14d
Days
Class 2
Risk

K021282 is an FDA 510(k) clearance for the LV-1 HEMOSTASIS VALVE, MODEL #6789. 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 2, 2002 after a review of 14 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guidant Corp. devices

Submission Details

510(k) Number K021282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2002
Decision Date May 02, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 67
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K021282.
6248VAL ADJUSTABLE VALVE
K052459 · Medtronic Vascular · Jan 2006
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · Guidant Corp. · May 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · Gish Biomedical, Inc. · Mar 2003
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp. · Feb 2001
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · Guidant Corp. · Jun 1999