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CorPassTM Introducer Sheath Set CPSH1325

by Cardiocycle Medical(Suzhou) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974949033839 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CorPassTM Introducer Sheath Set
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
CPSH1325
Primary DI / UDI-DI
06974949033839
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Introducer Sheath Compatibility — 13 French
Length — 25 Centimeter

Related devices

Cleared under the same submission (K254248)

Show all (12)

Other devices from Cardiocycle Medical(Suzhou) Co., Ltd.

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Properties

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

Other properties (10)

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