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510(k) K221464

CorPath GRX System by Corindus, Inc. — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2022
Date Received
May 19, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Corindus, Inc.

  • K202275 — CorPath GRX System (December 11, 2020)
  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)
  • K120834 — CORPATH 200 SYSTEM (July 19, 2012)

Other clearances for product code DXX

  • K251792 — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (November 6, 2025)
  • K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) (September 4, 2025)
  • K202275 — CorPath GRX System (December 11, 2020)
  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)
  • K151730 — Magellan Robotic System (July 23, 2015)