RADIUS COUGAR WIRE— 510(k) K032899

Clearance details

Applicant

Radius Medical Technologies, Inc.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2003-09-17

Decision date

2003-10-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Hopkonton, MA, US

• K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
• K253667 — Accoat Guide Wire2026-07-14
• K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
• K254137 — InQwire Amplatz Guide Wire2026-05-22
• K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

• K070502 — RADIUS SNARE2007-10-04
• K071457 — MODIFICATION TO RADIUS SNARE2007-09-25
• K032129 — RADIUS 018 COUGAR WIRE2003-07-17
• K022201 — RADIUS MICRO SNARE2003-02-03
• K021441 — RADIUS SNARE2002-06-14

Death

298

Injury

4,385

Malfunction

7,203

Other

5

Total

11,891

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 →

• Z-0261-2014 — Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S 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.Class I·Terminated·Medtronic Vascular·20131021
• Z-0266-2014 — COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S 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 anotherClass I·Terminated·Medtronic Vascular·20131021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032899.