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SPECTRUM MEDICAL SRL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30167462833016746283SPECTRUM MEDICAL SRL1N2027-01-01Via di Mezzo, 23 Mirandola Modena IT 41037

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2566171577923959K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR2026-03-12
2566171695295250K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM2025-08-04
2566171537984483K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM2025-06-24
2566171383796123K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF2024-05-31
2566171001433879K241206Quantum Perfusion Hybrid SystemDTN2024-07-18
2566171351045365K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);DTZ2026-03-12
2566171837859583K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)KFM2023-10-26
2566171556040885K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ2024-09-12
2566171897918765K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1UDTZ2023-11-08
2566171958038896K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR2023-04-13
2566171977655660K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VSDWF2022-08-18
2566172007952922K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsKFM2023-05-19
2566171875247351K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR2022-05-06
2566171693918023K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetDWF2022-05-20
2566171390111511K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR2022-01-10
2566171949469682K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2UDTZ2022-01-28
2566171411005838K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2DTZ2021-12-17
2566171508438461K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24FDWF2021-11-08
2566171121232202K203057Quantum Perfusion Arterial Cannula GraftDWF2021-06-30
2566172036439727K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM2020-09-02
2566172027119899K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorKFM2021-11-03
2566171006275214K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM2020-04-13
2566171497824657

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KFM72025-08-04
DTZ52026-03-12
DWF52024-05-31
DTR42026-03-12
DTN12024-07-18

GUDID#

119 records. Showing 1-40. Next