Skip to content

Globe® Platform 601-00066

by Kardium Inc

Globe® Platform 601-00066 is a Class I device made by Kardium Inc, listed in FDA GUDID since 15 Sep 2025 (UDI-DI 07540162100338), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540162100338 UDI-DI Date15 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Globe® Platform
Generic name
Cardiac implantation catheter platform base, single-use
Model / reference
601-00066
Primary DI / UDI-DI
07540162100338
FDA product code
QWA
GMDN term
Cardiac implantation catheter platform base, single-use
Device class
Class I
Regulation number
870.3955
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac implantation catheter platform base, single-use

Similar devices

Other devices filed under FDA product code QWA (Cardiovascular Delivery Catheter System Positioning And Stabilization Device).

Other devices from Kardium Inc

See all devices from Kardium Inc →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)