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CorPath GRX Cassette Duo 319

by Corindus, Inc.

CorPath GRX Cassette Duo 319 is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K221464 on 27 Jul 2022 and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 00816280023192), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K221464

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 Number00816280023192 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK221464 Date27 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221464 decided 27 Jul 2022 Active
  • FDA GUDID UDI-DI 00816280023192 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221464
  2. Listed FDA GUDID 00816280023192

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CorPath GRX Cassette Duo
Generic name
Cardiac mapping system workstation
Model / Ref / Catalog
319
Primary DI / UDI-DI
00816280023192
FDA product code
DXX
GMDN term
Cardiac mapping system workstation
Device class
Class II
Regulation number
870.1290
GUDID distribution status
Not 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 Corindus, Inc.

See all devices from Corindus, Inc. →

Properties

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