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FDA 510(k)

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

K-Number: K202176 · 2020-09-03

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2020-09-03
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202176. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K202176.

When did Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes receive FDA 510(k) clearance?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202176.

Who is the listed applicant for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA 510(k) record lists Medical Components, Inc. (dba MedComp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is MSD.

Other records listing Medical Components, Inc. (dba MedComp) as applicant

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.

K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsK192807Duo-Flow Side x Side Double Lumen CatheterK183219Trio-CT Triple Lumen CatheterK18117512F Tri-Flow Triple Lumen CatheterK17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with SideholesK180567C3 Wave System

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Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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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