Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sentinel Cerebral Protection System

K-Number: K192460 · 2020-02-19

ApplicantBoston Scientific Corporation
Decision Date2020-02-19
Product CodePUM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sentinel Cerebral Protection System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-02-19 under approval number K192460. The device is classified under product code PUM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentinel Cerebral Protection System?

Sentinel Cerebral Protection System is a medical device that received FDA 510(k) clearance on 2020-02-19. It is manufactured by Boston Scientific Corporation. The 510(k) number is K192460.

When was Sentinel Cerebral Protection System approved by the FDA?

Sentinel Cerebral Protection System received FDA 510(k) clearance on 2020-02-19, under approval number K192460.

What company makes Sentinel Cerebral Protection System?

Sentinel Cerebral Protection System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Sentinel Cerebral Protection System?

The FDA product code for Sentinel Cerebral Protection System is PUM.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07596550 Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

Related Devices (Code: PUM)

DEN160043Sentinel Cerebral Protection SystemClaret Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑