Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

K-Number: K241248 · 2024-05-31

ApplicantSpectrum Medical S.R.L.
Decision Date2024-05-31
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K241248. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241248.

When did Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) receive FDA 510(k) clearance?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K241248.

Who is the listed applicant for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA 510(k) record lists Spectrum Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is DWF.

Other records listing Spectrum Medical S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WK240934Quantum 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);K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)K241206Quantum Perfusion Hybrid System

Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑