Cleared Traditional

K052459 - 6248VAL ADJUSTABLE VALVE

K052459 is an FDA 510(k) clearance for 6248VAL ADJUSTABLE VALVE, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K052459 · Medtronic Vascular · Cardiovascular device
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Jan 2006
Decision
126d
Days
Class 2
Risk

K052459 is an FDA 510(k) clearance for the 6248VAL ADJUSTABLE VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 11, 2006 after a review of 126 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K052459

510(k) Number K052459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date January 11, 2006
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 102
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K052459.
Y-GLIDE
K072745 · Thomas Medical Products, Inc. · Jan 2008
HEMOSTASIS VALVE
K072556 · Merit Medical Systems, Inc. · Nov 2007
Y-CLICK CONNECTOR
K060759 · Elcam Medical Acal · Jun 2006
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
K042060 · Millimed A/S · Oct 2004
TERUMO CIRCUIT CONNECTORS
K041697 · Terumo Cardiovascular Systems Corporation · Aug 2004
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · Guidant Corp. · May 2003