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

FDA 510(k)

ViperCath XC Peripheral Exchange Catheter

K-Number: K183000 · 2018-12-29

ApplicantCardiovascular Systems, Inc.
Decision Date2018-12-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViperCath XC Peripheral Exchange Catheter is a medical device manufactured by Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2018-12-29 under approval number K183000. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViperCath XC Peripheral Exchange Catheter?

ViperCath XC Peripheral Exchange Catheter is a medical device that received FDA 510(k) clearance on 2018-12-29. It is manufactured by Cardiovascular Systems, Inc.. The 510(k) number is K183000.

When was ViperCath XC Peripheral Exchange Catheter approved by the FDA?

ViperCath XC Peripheral Exchange Catheter received FDA 510(k) clearance on 2018-12-29, under approval number K183000.

What company makes ViperCath XC Peripheral Exchange Catheter?

ViperCath XC Peripheral Exchange Catheter is manufactured by Cardiovascular Systems, Inc..

What is the FDA product code for ViperCath XC Peripheral Exchange Catheter?

The FDA product code for ViperCath XC Peripheral Exchange Catheter is DQY.

Related Clinical Trials

NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT06455228 Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy COMPLETED NCT01931579 Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. COMPLETED

Other Devices by Cardiovascular Systems, Inc.

K170792Diamondback 360 Peripheral Orbital Atherectomy System K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K200198WIRION

View all 14 devices →

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire 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.

↑