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Enabler-P Catheter System, Model 3000

by Endocross, Ltd.

510(k) K092174

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092174 Date30 Dec 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Enabler-P Catheter System, Model 3000 is a dual-lumen intravascular catheter (Device Type: DQY) designed for percutaneous use within the cardiovascular system. It facilitates access to remote venous sites and enables guidewire exchange while incorporating a distal balloon for targeted interventions.

This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K092174) under the Cardiovascular advisory committee. It requires compatibility with a 0.035-inch guidewire and is intended for use in interventional radiology or vascular surgery settings. Storage and handling must comply with sterile medical device protocols.

Other devices from Endocross, Ltd.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is the Enabler-P Catheter System, Model 3000, primarily designed to assist with in interventional radiology or vascular surgery?

    The Enabler-P Catheter System, Model 3000 is designed to facilitate access to remote venous sites within the cardiovascular system. Its dual-lumen design and distal balloon allow for targeted interventions, while also enabling guidewire exchange—useful for navigating complex vascular anatomies or when additional support is needed during procedures like venous access, catheter placement, or balloon angioplasty.

  • Is the Enabler-P Catheter System, Model 3000 compatible with standard guidewires, and if so, what size should clinicians use?

    Yes, the Enabler-P Catheter System is explicitly designed to be compatible with a 0.035-inch guidewire, which is a common standard in interventional cardiology and vascular procedures. This compatibility ensures smooth navigation and exchange of guidewires during procedures without requiring specialized equipment.

  • How should the Enabler-P Catheter System, Model 3000 be stored and handled to maintain sterility?

    The system is supplied sterile and intended for single-use only, so it must be stored and handled according to standard sterile medical device protocols. This includes keeping the packaging intact until immediate use, avoiding contamination, and adhering to facility-specific guidelines for sterile instrument preparation to prevent compromise of sterility before deployment.

  • What regulatory pathway was followed for FDA clearance of the Enabler-P Catheter System, Model 3000, and which committee reviewed it?

    The Enabler-P Catheter System, Model 3000 received FDA 510(k) clearance (K092174) under the Traditional review pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. The Cardiovascular (CV) Advisory Committee reviewed the submission, which was filed on July 21, 2009, and cleared on December 30, 2009, under the DQY product code for intravascular catheters.