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SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3003

by East End Medical I, LLC

Listed FDA GUDID listing, not in commercial distribution

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 Number08600035053037 UDI-DI Date13 Apr 2022ListedStatusListed GUDID: not 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  • Withdrawn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
SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Generic Name
Cardiac septostomy catheter, balloon
Model / Ref / Catalog
3003
Primary DI / UDI-DI
08600035053037
510(k) Number
FDA Product Code
DYB
GMDN Term
Cardiac septostomy catheter, balloon
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
Not in Commercial Distribution

Other devices from East End Medical I, LLC

Properties

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

Other properties (8)

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