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FDA 510(k)

Deklene MAXX

K-Number: K193530 · 2020-03-19

ApplicantTeleflex Medical
Decision Date2020-03-19
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Deklene MAXX is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2020-03-19 under approval number K193530. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deklene MAXX?

Deklene MAXX is a medical device that received FDA 510(k) clearance on 2020-03-19. It is manufactured by Teleflex Medical. The 510(k) number is K193530.

When was Deklene MAXX approved by the FDA?

Deklene MAXX received FDA 510(k) clearance on 2020-03-19, under approval number K193530.

What company makes Deklene MAXX?

Deklene MAXX is manufactured by Teleflex Medical.

What is the FDA product code for Deklene MAXX?

The FDA product code for Deklene MAXX is GAW.

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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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