SKIPPER AND SKIPPER RACE GUIDEWIRE— 510(k) K050756

Clearance details

Applicant

Invatec Innovative Technologies, S.R.L.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2005-03-23

Decision date

2005-05-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plymouth, MN, US

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• 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

• K083919 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2009-03-13
• K052791 — MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2005-11-04
• K051917 — DIVER C.E. CATHETER2005-08-08
• K050276 — DIVER C.E. CATHETER2005-03-07
• K050073 — MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2005-02-11

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 →