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FDA 510(k)

C3 Wave System

K-Number: K180567 · 2018-04-12

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2018-04-12
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C3 Wave System is a medical device manufactured by Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2018-04-12 under approval number K180567. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C3 Wave System?

C3 Wave System is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Medical Components, Inc. (dba MedComp). The 510(k) number is K180567.

When was C3 Wave System approved by the FDA?

C3 Wave System received FDA 510(k) clearance on 2018-04-12, under approval number K180567.

What company makes C3 Wave System?

C3 Wave System is manufactured by Medical Components, Inc. (dba MedComp).

What is the FDA product code for C3 Wave System?

The FDA product code for C3 Wave System is LJS.

Other Devices by Medical Components, Inc. (dba MedComp)

K170770CT Midline K18117512F Tri-Flow Triple Lumen Catheter K17366715.5F 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 Sideholes K183219Trio-CT Triple Lumen Catheter K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes K192807Duo-Flow Side x Side Double Lumen Catheter

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Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH 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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