FlexCath Select Steerable Shealth and Dilator— 510(k) K163268

Substantially Equivalent

Medtronic Cryocath, LP

FDA 510(k) clearance K163268 for FlexCath Select Steerable Shealth and Dilator, Substantially Equivalent on 2017-02-02. Applicant: Medtronic Cryocath, LP.

Clearance details

Applicant: Medtronic Cryocath, LP
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2016-11-21
Decision date: 2017-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.