RX ACCUNET LP EMBOLIC PROTECTION SYSTEM— 510(k) K081549

Clearance details

Applicant

Abbott Laboratories

Product code

Code NTE

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2008-06-03

Decision date

2008-08-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Clara, CA, US

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Death

28

Injury

1,348

Malfunction

771

Total

2,147

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-0757-2013 — Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.Class II·Terminated·Abbott Vascular·20111130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081549.