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

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 the device name listed in this FDA 510(k) record. The listed applicant is Marblehead Medical. It received FDA 510(k) clearance on 2020-05-02 under 510(k) 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. The listed applicant is Marblehead Medical. The 510(k) number is K200910.

When did BOSS Balloon Guide Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for BOSS Balloon Guide Catheter?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Marblehead Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203840BOSS 8F Balloon Guide Catheter

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

↑