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V-Loop Variable Loop Catheter Manipulator 1

by Stereotaxis, Inc.

V-Loop Variable Loop Catheter Manipulator 1 (001-002452-1) is a Class II device made by Stereotaxis, Inc., listed in FDA GUDID since 2 May 2016 (UDI-DI M58800100245210), 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 NumberM58800100245210 UDI-DI Date2 May 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
V-Loop Variable Loop Catheter Manipulator
Generic name
Cardiac mapping system workstation
Model / Ref / Catalog
1, 001-002452-1
Primary DI / UDI-DI
M58800100245210
FDA product code
DXX, DQX
GMDN term
Cardiac mapping system workstation
Device class
Class II
Regulation number
870.1290, 870.1330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system workstation

Similar devices

Other devices filed under FDA product code DXX (System, Catheter Control, Steerable).

Other devices from Stereotaxis, Inc.

  • Niobe MNS Omega ES Omega

    Class II

  • GenesisX 1

    Class II

  • GenesisX RMN

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  • Navigant

    Class IIb

See all devices from Stereotaxis, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)