FDA 510(k)

DOUBLEFLO system

K-Number: K203480 · 2021-04-05

Decision Date2021-04-05

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DOUBLEFLO system is a medical device manufactured by Hemodia Sas. It received FDA 510(k) clearance on 2021-04-05 under approval number K203480. 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 system?

DOUBLEFLO system is a medical device that received FDA 510(k) clearance on 2021-04-05. It is manufactured by Hemodia Sas. The 510(k) number is K203480.

When was DOUBLEFLO system approved by the FDA?

DOUBLEFLO system received FDA 510(k) clearance on 2021-04-05, under approval number K203480.

What company makes DOUBLEFLO system?

DOUBLEFLO system is manufactured by Hemodia Sas.

What is the FDA product code for DOUBLEFLO system?

The FDA product code for DOUBLEFLO system is HRX.

Other Devices by Hemodia Sas

K192921Zeos Aqua Vision Pump and tube K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

Official Source

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