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FDA 510(k)

BOSS 8F Balloon Guide Catheter

K-Number: K203840 · 2021-01-28

ApplicantMarblehead Medical, LLC
Decision Date2021-01-28
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOSS 8F Balloon Guide Catheter is a medical device manufactured by Marblehead Medical, LLC. It received FDA 510(k) clearance on 2021-01-28 under approval number K203840. 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 8F Balloon Guide Catheter?

BOSS 8F Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Marblehead Medical, LLC. The 510(k) number is K203840.

When was BOSS 8F Balloon Guide Catheter approved by the FDA?

BOSS 8F Balloon Guide Catheter received FDA 510(k) clearance on 2021-01-28, under approval number K203840.

What company makes BOSS 8F Balloon Guide Catheter?

BOSS 8F Balloon Guide Catheter is manufactured by Marblehead Medical, LLC.

What is the FDA product code for BOSS 8F Balloon Guide Catheter?

The FDA product code for BOSS 8F Balloon Guide Catheter is QJP.

Related Clinical Trials

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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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