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FDA 510(k)

BOSS Balloon Guide Catheter

K-Number: K200910 · 2020-05-02

ApplicantMarblehead Medical
Decision Date2020-05-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOSS Balloon Guide Catheter is a medical device manufactured by Marblehead Medical. It received FDA 510(k) clearance on 2020-05-02 under approval number K200910. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSS Balloon Guide Catheter?

BOSS Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-05-02. It is manufactured by Marblehead Medical. The 510(k) number is K200910.

When was BOSS Balloon Guide Catheter approved by the FDA?

BOSS Balloon Guide Catheter received FDA 510(k) clearance on 2020-05-02, under approval number K200910.

What company makes BOSS Balloon Guide Catheter?

BOSS Balloon Guide Catheter is manufactured by Marblehead Medical.

What is the FDA product code for BOSS Balloon Guide Catheter?

The FDA product code for BOSS Balloon Guide Catheter is QJP.

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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.

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