FDA.reportPublic FDA data

510(k) K261715

Device
Emboliner Embolic Protection System (EPC-03)
Applicant
Emboline, Inc.
510(k) number
K261715
Product code
PUM
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-08
Date received
2026-05-22
Regulation
870.1251
Classification name
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Will Michul
Address
2901 Mission St. Bldg. 2 Santa Cruz CA US 95060 95060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PUM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192460Sentinel Cerebral Protection SystemBoston Scientific Corporation2020-02-19
DEN160043Sentinel Cerebral Protection SystemClaret Medical, Inc.2017-06-01