FDA.reportPublic FDA data

510(k) K192460

Device
Sentinel Cerebral Protection System
Applicant
Boston Scientific Corporation
510(k) number
K192460
Product code
PUM  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-19
Date received
2019-09-09
Regulation
870.1251
Classification name
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eric Elliott
Address
Three Scimed Pl. Maple Grove MN US 55311 55311

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
DEN160043Sentinel Cerebral Protection SystemClaret Medical, Inc.2017-06-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases