Prelude Pursuit Splittable Sheath Introducer— 510(k) K172117

Unknown

Merit Medical Systems, Inc.

FDA 510(k) clearance K172117 for Prelude Pursuit Splittable Sheath Introducer, Unknown on 2017-09-11. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2017-07-13
Decision date: 2017-09-11
Decision: Unknown
Clearance type: Traditional
Location: Malvern, PA, 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.