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Emboliner Embolic Protection System EPC-03

by Emboline, Inc.

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 Number00860005743629 UDI-DI Date24 Sep 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  • Withdrawn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
Emboliner Embolic Protection System
Generic Name
Embolic protection filtering catheter
Model / Reference
EPC-03
Primary DI / UDI-DI
00860005743629
510(k) Number
FDA Product Code
PUM
GMDN Term
Embolic protection filtering catheter
Device Class
Class II
Regulation Number
870.1251
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Other devices from Emboline, Inc.

Properties

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

Other properties (7)

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