Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C3 Wave System

K-Number: K170934 · 2017-12-06

ApplicantMedical Components, Inc (Dba Medcomp_
Decision Date2017-12-06
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C3 Wave System 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 2017-12-06 under 510(k) number K170934. 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 2017-12-06. The listed applicant is Medical Components, Inc (Dba Medcomp_. The 510(k) number is K170934.

When did C3 Wave System receive FDA 510(k) clearance?

C3 Wave System received FDA 510(k) clearance on 2017-12-06, under 510(k) number K170934.

Who is the listed applicant for C3 Wave System?

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 C3 Wave System?

The FDA product code for C3 Wave System is LJS.

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 ExtensionsK202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesK192807Duo-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 Sideholes

View all 9 devices →

Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, 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.

↑