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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 the device name listed in this FDA 510(k) record. The listed applicant is Hk Surgical. It received FDA 510(k) clearance on 2020-09-09 under 510(k) 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. The listed applicant is Hk Surgical. The 510(k) number is K193664.

When did SubQKath Catheter and Needle Set receive FDA 510(k) clearance?

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

Who is the listed applicant for SubQKath Catheter and Needle Set?

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

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

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

Related Devices (Code: BSO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax ApsK181782Medline Reinforced Epidural CatheterMedline Industries, Inc.

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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