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Quantum Micro-Cardioplegia Delivery System - Quantum Micro-Cardioplegia Delivery Module (QMCDM)

by Spectrum Medical Ltd 510(k)

Active United States

510(k) K240908

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240908 Date8 Jul 2025ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DTR
Models / Variants
Quantum Micro-Cardioplegia Delivery Module (QMCDM)
FDA applicant
Spectrum Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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