Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016746283

FEI Number

3016746283

Entity Name

SPECTRUM MEDICAL SRL

City/State/Country

Mirandola Modena, IT

Establishment Address

Via di Mezzo, 23, Mirandola Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spectrum Medical SRL (Owner Number: 10069754)

Owner / Operator Contact Address

Via di Mezzo, 23, Mirandola, IT-MO 41037, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231773

PMA Number

N/A

All Registered Proprietary Names

QUANTUM PERFUSION HYBRID SYSTEM QUANTUM PERFUSION BLOOD OXYGENATOR VT200-E3 QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E3 QUANTUM PERFUSION BLOOD OXYGENATOR VT160-E3 QUANTUM PUREFLOW STANDARD HEAT EXCHANGER QUANTUM PERFUSION DUAL LUMEN CANNULA QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20 WITH INTEGRATED SENSORS QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20 Quantum PureFlow Standard Heat Exchanger Quantum PureFlow Cardioplegia Heat Exchanger QUANTUM SUPERPAC CARDIOPLEGIA Quantum Perfusion Arterial Cannula Graft KIT CPC QUANTUM PERFUSION CAPNOMETER LINE SET QUANTUM SUPERPAC TUBING SET QUANTUM SUPERPAC CARDIOPLEGIA SET KIT QUANTUM SUPERPAC TUBING SET QUANTUM SUPERPAC ADAPTER TUBING SET QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37 WITH INTEGRATED SENSORS Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22NG WITH INTEGRATED SENSORS QUANTUM PERFUSION DUAL LUMEN CANNULA 31F-V1 Quantum Perfusion Blood Oxygenator QUANTUM SUPERPAC CPB QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E1 QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E2 QUANTUM SUPERPAC CPB QUANTUM PERFUSION BLOOD OXYGENATOR WITH INTEGRATED AF AND SENSOR QUANTUM PERFUSION BLOOD OXYGENATOR WITH INTEGRATED AF QUANTUM SUPERPAC CPB QUANTUM PUREFLOW CARDIOPLEGIA HEAT EXCHANGER QUANTUM PUREFLOW STANDARD HEAT EXCHANGER Quantum Perfusion Centrifugal Blood Pump Quantum PureFlow Centrifugal Blood Pump QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20NG WITH INTEGRATED SENSORS Quantum PureFlow Centrifugal Blood Pump QUANTUM PERFUSION BLOOD OXYGENATOR with INTEGRATED AF QUANTUM PERFUSION BLOOD OXYGENATOR with INTEGRATED AF AND SENSOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2024-08-01
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2026-03-30
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-05-03
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2022-09-02
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2023-05-29
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2022-05-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-08-04
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2022-03-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2022-05-24
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2023-11-03
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2021-11-10
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2025-07-03
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-06-19
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2021-12-22
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2024-10-24
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2022-02-03
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2022-01-17
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2020-10-12
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2025-08-12
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2020-04-16
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-11-21

Official Correspondent

Raffaella Tommasini

US Agent Details

Cameron Schmitt Business: Spectrum Medical Inc. Email: cameron.schmitt@spectrummedical.com Phone: (803) 8333964

Related Public Records

Same Entity

Spectrum Medical SRL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862357	3M Health Care, Sarns	MODIFIED CARDIOTOMY RESERVOIR 5M1470	1986-08-19
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016746283. Last updated year: 2026. Please use registration number 3016746283 when referencing this establishment in official correspondence.