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FDA 510(k)

SubQKath Catheter and Needle Set

K-Number: K193664 · 2020-09-09

ApplicantHk Surgical
Decision Date2020-09-09
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SubQKath Catheter and Needle Set is a medical device manufactured by Hk Surgical. It received FDA 510(k) clearance on 2020-09-09 under approval number K193664. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SubQKath Catheter and Needle Set?

SubQKath Catheter and Needle Set is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by Hk Surgical. The 510(k) number is K193664.

When was SubQKath Catheter and Needle Set approved by the FDA?

SubQKath Catheter and Needle Set received FDA 510(k) clearance on 2020-09-09, under approval number K193664.

What company makes SubQKath Catheter and Needle Set?

SubQKath Catheter and Needle Set is manufactured by Hk Surgical.

What is the FDA product code for SubQKath Catheter and Needle Set?

The FDA product code for SubQKath Catheter and Needle Set is BSO.

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Related Devices (Code: BSO)

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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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