Cleared Traditional

K060759 - Y-CLICK CONNECTOR

K060759 is an FDA 510(k) clearance for Y-CLICK CONNECTOR, manufactured by Elcam Medical Acal. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K060759 · Elcam Medical Acal · Cardiovascular device
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Jun 2006
Decision
100d
Days
Class 2
Risk

K060759 is an FDA 510(k) clearance for the Y-CLICK CONNECTOR. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Elcam Medical Acal (D.N. Merom Hagalil, IL). The FDA issued a Cleared decision on June 29, 2006 after a review of 100 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 Elcam Medical Acal devices

FDA 510(k) Submission Details - K060759

510(k) Number K060759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2006
Decision Date June 29, 2006
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 86
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K060759.
GATOR CLIPSEAL PLUG
K092563 · Vascular Solutions, Inc. · Nov 2009
Y-GLIDE
K072745 · Thomas Medical Products, Inc. · Jan 2008
HEMOSTASIS VALVE
K072556 · Merit Medical Systems, Inc. · Nov 2007
6248VAL ADJUSTABLE VALVE
K052459 · Medtronic Vascular · Jan 2006
TERUMO CIRCUIT CONNECTORS
K041697 · Terumo Cardiovascular Systems Corporation · Aug 2004
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · Guidant Corp. · May 2003