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Viapeel Peelable Introducer

by Enpath Medical, Inc. 510(k)

Active United States

510(k) K072248

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK072248 Date9 Nov 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2781-2017 FDA Class II initiated 11 Nov 2016

    Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

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

Other devices from Enpath Medical, Inc.