Guider Catheter Introducer— 510(k) K171081

Substantially Equivalent

Rhythm Xience, Inc. (Rxi)

FDA 510(k) clearance K171081 for Guider Catheter Introducer, Substantially Equivalent on 2017-05-09. Applicant: Rhythm Xience, Inc. (Rxi).

Clearance details

Applicant: Rhythm Xience, Inc. (Rxi)
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2017-04-11
Decision date: 2017-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, 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.