RADIUS PTCA GUIDEWIRE— 510(k) K970466
Substantially EquivalentRadius Medical Technologies, Inc.
FDA 510(k) clearance K970466 for RADIUS PTCA GUIDEWIRE, Substantially Equivalent on 1997-05-20. Applicant: Radius Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Radius Medical Technologies, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maynard, MA, US
Recent devices under product code LIT
view allMore clearances from Radius Medical Technologies, Inc.
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K970466
K-number listed on FDA's recall record- Z-0263-2014 — THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
- Z-0267-2014 — THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970466.
Data sourced from openFDA. This site is unofficial and independent of the FDA.