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FDA 510(k)

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set

K-Number: K211104 · 2021-08-19

Decision Date2021-08-19
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2021-08-19 under approval number K211104. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Conmed Corporation. The 510(k) number is K211104.

When was AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set approved by the FDA?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set received FDA 510(k) clearance on 2021-08-19, under approval number K211104.

What company makes AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is manufactured by Conmed Corporation.

What is the FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

The FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is HIF.

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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.