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Y-Click Connector

by Elcam Medical ACAL 510(k)

Active United States

510(k) K060759

Overview

The Y-Click Connector is a hemostatic valve adaptor, stopcock, manifold, and fitting designed for use in cardiopulmonary bypass and interventional procedures. It functions as a fluid control device to manage blood loss and facilitate catheter-based interventions by providing a sealed pathway for guide-wires, catheters, and contrast media injection while maintaining hemostasis.

This device is intended for single-use in interventional cardiology and cath lab settings, where it connects to angiographic catheters. It features a slit septum for guide-wire and catheter passage, a side arm for contrast media injection, saline flushing, and blood pressure monitoring. The Y-Click Connector is classified as a Class II medical device under FDA regulations (K060759, DTL) and has received 510(k) clearance for cardiovascular applications.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060759 Date29 Jun 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Y-Click Connector used for in clinical settings?

    The Y-Click Connector is designed as a hemostatic valve adaptor, stopcock, manifold, and fitting for cardiopulmonary bypass and interventional procedures. It controls blood flow, prevents leaks, and allows passage of guide-wires, catheters, and contrast media injection—critical for maintaining hemostasis during catheter-based interventions in cath labs.

  • Is the Y-Click Connector intended for single-use or reuse?

    This device is explicitly designed for single-use only in interventional cardiology and cath lab environments. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and functionality.

  • What features does the Y-Click Connector include for fluid control?

    The Y-Click Connector integrates a slit septum for guide-wire and catheter passage, a side arm for contrast media injection and saline flushing, and ports for blood pressure monitoring. These components collectively enable precise fluid management while maintaining a sealed pathway.

  • How is the Y-Click Connector supplied, and what should clinicians verify before use?

    The device is supplied sterile and ready for immediate use in its original packaging. Clinicians should confirm the sterility seal is intact, inspect for visible damage, and ensure compatibility with their angiographic catheters before connecting it to the bypass circuit or interventional setup.

  • What regulatory pathway does the Y-Click Connector follow?

    The Y-Click Connector has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (K060759). It is intended for cardiovascular applications and adheres to FDA regulations for adaptors, stopcocks, manifolds, and fittings in cardiopulmonary bypass systems.