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VSI Micro-HV Introducer Kit CLI-800-28

by Galt Medical Corp.

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

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

510(k) K043525

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841268106581 UDI-DI Date28 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK043525 Date9 Feb 2005IssuedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1733-2025 FDA Class II initiated 27 Mar 2025

    Due to a potential open seal in the sterile barrier packaging .

  • 2 recalls, same reason

    • Terminated Z-2562-2018 FDA Class II initiated 2 May 2018
    • Terminated Z-2558-2018 FDA Class II initiated 2 May 2018

    The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VSI Micro-HV Introducer Kit
Generic name
Haemostasis valve
Model / Ref / Catalog
CLI-800-28
Primary DI / UDI-DI
00841268106581
FDA product code
DYB
GMDN term
Haemostasis valve
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
Size
Catheter Gauge — 7 French

Related devices

Category: Haemostasis valve

Cleared under the same submission (K043525)

Show all (9)

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date

Other properties (8)

  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Manufacturing date: No