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SAT CenterFlow Molding Balloon Catheter IN20-00313

by Strait Access Technologies Holdings

Listed FDA GUDID listing, not in commercial distribution

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 Number06009880940004 UDI-DI Date1 Dec 2025ListedStatusListed GUDID: not 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  • Withdrawn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
SAT CenterFlow Molding Balloon Catheter
Generic Name
Aortic endovascular implant post-dilation balloon catheter
Model / Ref / Catalog
IN20-00313
Primary DI / UDI-DI
06009880940004
510(k) Number
FDA Product Code
DQY
GMDN Term
Aortic endovascular implant post-dilation balloon catheter
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Strait Access Technologies Holdings

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