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FDA 510(k)

DiscCath Needle Set

K-Number: K212328 · 2021-09-26

ApplicantDisccath, LLC
Decision Date2021-09-26
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DiscCath Needle Set is a medical device manufactured by Disccath, LLC. It received FDA 510(k) clearance on 2021-09-26 under approval number K212328. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiscCath Needle Set?

DiscCath Needle Set is a medical device that received FDA 510(k) clearance on 2021-09-26. It is manufactured by Disccath, LLC. The 510(k) number is K212328.

When was DiscCath Needle Set approved by the FDA?

DiscCath Needle Set received FDA 510(k) clearance on 2021-09-26, under approval number K212328.

What company makes DiscCath Needle Set?

DiscCath Needle Set is manufactured by Disccath, LLC.

What is the FDA product code for DiscCath Needle Set?

The FDA product code for DiscCath Needle Set is BSP.

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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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