Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)— 510(k) K190282

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K190282 for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand), Substantially Equivalent on 2019-05-24. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2019-02-11
Decision date: 2019-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.