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CorPassTM Introducer Sheath Set CPSH1715

by Cardiocycle Medical(Suzhou) Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974949033983 UDI-DIDate20 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
CorPassTM Introducer Sheath Set
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
CPSH1715
Primary DI / UDI-DI
06974949033983
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 — 17 French
Length — 15 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