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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-02-19 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K192460.

When did Sentinel Cerebral Protection System receive FDA 510(k) clearance?

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

Who is the listed applicant for Sentinel Cerebral Protection System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

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Official Source

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

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