510(k) K240908— Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

Substantially Equivalent

Spectrum Medical , Ltd.

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2024-04-02
Decision date: 2025-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.