IN-TIME RETRIEVAL DEVICE— 510(k) K014109

Name: FDA 510(k) clearance K014109
Creator: U.S. Food and Drug Administration
Published: 2002-03-12

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K014109 for IN-TIME RETRIEVAL DEVICE, Substantially Equivalent on 2002-03-12. Applicant: Boston Scientific, Target. Device class: 2.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2001-12-14
Decision date: 2002-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.