MICRO GUIDE CATHETER ELITE— 510(k) K140438

Clearance details

Applicant

Cordis Corp., A Johnson & Johnson Co.

Product code

Code PDU

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2014-02-21

Decision date

2014-11-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fremont, CA, US

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Malfunction

793

Total

793

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 →