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)

Pioneer Plus Catheter

K-Number: K162418 · 2016-12-02

ApplicantPhilips Volcano
Decision Date2016-12-02
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pioneer Plus Catheter is a medical device manufactured by Philips Volcano. It received FDA 510(k) clearance on 2016-12-02 under approval number K162418. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pioneer Plus Catheter?

Pioneer Plus Catheter is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by Philips Volcano. The 510(k) number is K162418.

When was Pioneer Plus Catheter approved by the FDA?

Pioneer Plus Catheter received FDA 510(k) clearance on 2016-12-02, under approval number K162418.

What company makes Pioneer Plus Catheter?

Pioneer Plus Catheter is manufactured by Philips Volcano.

What is the FDA product code for Pioneer Plus Catheter?

The FDA product code for Pioneer Plus Catheter is PDU.

Other Devices by Philips Volcano

K170133FFR V2.5

Related Devices (Code: PDU)

K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc K183357XableCath Crossing CatheterXablecath, Inc. K201330Tigereye CTO-Crossing CatheterAvinger, Inc. K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. K203363Crosser iQ CTO Recanalization SystemC.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.

↑