Emboliner Embolic Protection System

Primary DI
00860005743629
Brand
Emboliner Embolic Protection System
Company
Emboline, Inc.
Model
EPC-03
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac ProceduresCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261715000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261715000Emboliner Embolic Protection System (EPC-03)Emboline, Inc.2026-09-08PUM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005743629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005743629008600057436298600057436290860005743629

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering catheterA flexible tube with a distal filter intended for temporary, percutaneous introduction within a blood vessel (e.g., aortic arch) during a cardiovascular procedure, to provide protection from cerebral and/or pulmonary embolism by filtering emboli while maintaining blood vessel patency; some types provide a working channel for additional interventional devices; it is not intended for use in the coronary or cerebral vasculature. The filter expands upon deployment and imparts an outward radial force on the luminal surface of the blood vessel to facilitate stability and full filtering; the emboli may be captured or deflected. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+31889951333info@ar-experts.eu
+18319005020info@emboline.com

Regulatory Flags#

DUNS number
056234950
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863229000004SentinelBOSTON SCIENTIFIC CORPORATIONPUM2018-06-12