pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire— 510(k) K191687

Substantially Equivalent

Phenox Limited

FDA 510(k) clearance K191687 for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire, Substantially Equivalent on 2019-10-09. Applicant: Phenox Limited.

Clearance details

Applicant: Phenox Limited
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2019-06-24
Decision date: 2019-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.