TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088— 510(k) K040447

Name: FDA 510(k) clearance K040447
Creator: U.S. Food and Drug Administration
Published: 2004-03-12

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K040447 for TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088, Substantially Equivalent on 2004-03-12. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LQC
Device class: Class 2
Regulation: 21 CFR 876.4500
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-20
Decision date: 2004-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR1994-08-29
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Adverse events under product code LQC

product code LQC

Death: 7
Injury: 247
Malfunction: 956
Total: 1,210

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.