Estech Percutaneous Insertion Dilator Kit

by Coombs Medical Device Consulting

510(k) K070749

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

510(k) K070749↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK070749	Date24 Oct 2007Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K070749
FDA Product Code: DRE

Device Class: Class II
Regulation: 21 CFR Part 870.1310
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Estech Percutaneous Insertion Dilator Kit is a dilator, vessel, for percutaneous catheterization (OpenFDA classification). It is designed to facilitate the insertion of catheters or cannulas through the skin into blood vessels, reducing trauma and improving ease of placement during percutaneous procedures. The kit includes dilators of varying sizes to accommodate different vessel diameters and patient anatomies, ensuring compatibility with standard catheterization techniques.

This single-use, non-sterile device is intended for use in surgical settings, including interventional radiology and cardiology. It is supplied as a sterile kit upon opening and must be used immediately to maintain sterility. The kit is classified as a Class II medical device under FDA regulations (21 CFR 870.1310) and holds a FDA 510(k) clearance (K070749) as substantially equivalent to predicate devices. No MRI safety information is specified, and proper disposal follows standard biomedical waste protocols.