FILTER DEVICES— 510(k) K761098

Clearance details

Applicant

Arrow Intl., Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1976-11-22

Decision date

1977-01-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K071111 — NON-ABSORBABLE SILK SUTURE2007-07-17

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

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 →