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Ptfe Interlock Peelable Introducers

by Enpath Medical, Inc. 510(k)

Active United States

510(k) K081394

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081394 Date15 Sep 2008ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Ptfe Interlock Peelable Introducers are medical devices designed to facilitate the introduction of catheters or other instruments into the vascular system. The kit includes a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles.

These devices are available in various lengths ranging from 3.5F through 7F for micro applications and 7F through 16.5F for macro applications. The product has received FDA 510k clearance and is classified as a Class 2 medical device under product code DYB.

Other devices from Enpath Medical, Inc.