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FDA 510(k)

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

K-Number: K221919 · 2023-03-09

ApplicantHemodia Sas
Decision Date2023-03-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is a medical device manufactured by Hemodia Sas. It received FDA 510(k) clearance on 2023-03-09 under approval number K221919. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Hemodia Sas. The 510(k) number is K221919.

When was DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets approved by the FDA?

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets received FDA 510(k) clearance on 2023-03-09, under approval number K221919.

What company makes DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is manufactured by Hemodia Sas.

What is the FDA product code for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

The FDA product code for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is HRX.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Other Devices by Hemodia Sas

K192921Zeos Aqua Vision Pump and tube K203480DOUBLEFLO system

Related Devices (Code: HRX)

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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.

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