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POWERWAND™ XL 4Fr x 8cm

by ICU Medical, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K131300

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10859821006015 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK131300 Date7 Jun 2013DecidedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2254-2013 FDA Class II initiated 16 Aug 2013

    Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Powerwand™ Xl
Generic name
Peripheral vascular catheter
Model / Ref / Catalog
4Fr x 8cm, 94102
Primary DI / UDI-DI
10859821006015
510(k) Number
FDA product code
DYB
GMDN term
Peripheral vascular catheter
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Centimeter
Catheter Gauge — 4 French

Related devices

Category: Peripheral vascular catheter

Cleared under the same submission (K131300)

Show all (10)

Other devices from ICU Medical, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No