AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter— 510(k) K201081

Substantially Equivalent

Philips Medical System Nederland B.V.

FDA 510(k) clearance K201081 for AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter, Substantially Equivalent on 2020-12-17. Applicant: Philips Medical System Nederland B.V..

Clearance details

Applicant: Philips Medical System Nederland B.V.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2020-04-22
Decision date: 2020-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Best, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.