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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2020-03-19 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K193530.

When did Deklene MAXX receive FDA 510(k) clearance?

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

Who is the listed applicant for Deklene MAXX?

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

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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