BOSS 8F Balloon Guide Catheter— 510(k) K203840

Name: FDA 510(k) clearance K203840
Creator: U.S. Food and Drug Administration
Published: 2021-01-28

Substantially Equivalent

Marblehead Medical, LLC

FDA 510(k) clearance K203840 for BOSS 8F Balloon Guide Catheter, Substantially Equivalent on 2021-01-28. Applicant: Marblehead Medical, LLC. Device class: 2.

Clearance details

Applicant: Marblehead Medical, LLC
Product code: Code QJP
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2020-12-31
Decision date: 2021-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester Mn, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.