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CorPath GRX System

by Corindus, Inc. 6 variants

510(k) K221464

CorPath GRX System is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K221464 on 27 Jul 2022, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221464 Date27 Jul 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXX
Device class
Class II
Regulation
21 CFR Part 870.1290
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K221464

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221464
UDI-DISize and differences
CorPath GRX Cassette Duo 319
Corindus, Inc.
319 / 31900816280023192 —No longer on the market

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. →