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KardiaPSI CVPSI2025

by Intervention Tech, Inc. ; dba Corvention

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG825CVPSI20251 UDI-DI Date24 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
KardiaPSI
Generic Name
Cardiac valvuloplasty catheter
Model / Ref / Catalog
CVPSI2025
Primary DI / UDI-DI
G825CVPSI20251
510(k) Number
FDA Product Code
OZT
GMDN Term
Cardiac valvuloplasty catheter
Device Class
Class II
Regulation Number
870.1255
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 20 Millimeter

Related devices

Cleared under the same submission (K253855)

Show all (10)

Other devices from Intervention Tech, Inc. ; dba Corvention

See all devices from Intervention Tech, Inc. ; dba Corvention →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No