BRACHIAL CORONARY GUIDING CATHETER— 510(k) K822862

Clearance details

Applicant

Advanced Cardiovascular Systems, Inc.

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

1982-09-27

Decision date

1982-10-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Clara, CA, US

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• K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE1999-10-28
• K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-181999-09-02

Death

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

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 →