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3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers - 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers

by C.R. Bard, Inc (Bard Has Joined Bd)

510(k) K180548

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK180548 Date26 Apr 2018ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2664-2026 FDA Class II initiated 21 May 2026

    Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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  • Withdrawn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
LJS
Models / Variants
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent