DIVER C.E. CATHETER— 510(k) K051917

Clearance details

Applicant

Invatec Innovative Technologies, S.R.L.

Product code

Code QEZ

Device class

Class 2

Regulation

21 CFR 870.5150

Advisory panel

Cardiovascular

Date received

2005-07-15

Decision date

2005-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plymouth, MN, US

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• K254208 — FLOWRUNNER Aspiration System2026-03-20

• K083919 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2009-03-13
• K052791 — MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2005-11-04
• K050756 — SKIPPER AND SKIPPER RACE GUIDEWIRE2005-05-05
• K050276 — DIVER C.E. CATHETER2005-03-07
• K050073 — MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER2005-02-11

Death

24

Total

24

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-1517-2013 — lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.Class II·Terminated·Invatec Llc·20090304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051917.