MODIFICATION TO RADIUS SNARE— 510(k) K071457

Name: FDA 510(k) clearance K071457
Creator: U.S. Food and Drug Administration
Published: 2007-09-25

Substantially Equivalent

Radius Medical Technologies, Inc.

FDA 510(k) clearance K071457 for MODIFICATION TO RADIUS SNARE, Substantially Equivalent on 2007-09-25. Applicant: Radius Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Radius Medical Technologies, Inc.
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2007-05-25
Decision date: 2007-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Radius Medical Technologies, Inc.

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K070502 — RADIUS SNARE2007-10-04
K032899 — RADIUS COUGAR WIRE2003-10-17
K032129 — RADIUS 018 COUGAR WIRE2003-07-17
K022201 — RADIUS MICRO SNARE2003-02-03
K021441 — RADIUS SNARE2002-06-14

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.