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VIVO System 9002

by Catheter Precision, Inc

VIVO System 9002 is a cardiac mapping system application software (FDA Class II; FDA product code DQK, Computer, Diagnostic, Programmable) made by Catheter Precision, Inc, cleared under FDA 510(k) K200313 on 14 Sep 2020 and listed in FDA GUDID since 3 Feb 2026 (UDI-DI 00851424007119), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K200313

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851424007119 UDI-DI Date3 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK200313 Date14 Sep 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200313 decided 14 Sep 2020 Active
  • FDA GUDID UDI-DI 00851424007119 listed 3 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200313
  2. Listed FDA GUDID 00851424007119

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VIVO System
Generic name
Cardiac mapping system application software
Model / Ref / Catalog
9002
Primary DI / UDI-DI
00851424007119
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system application software
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from Catheter Precision, Inc

See all devices from Catheter Precision, Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)