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VOLCANO CORPORATION

USA · San Diego

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

20listed device types

Class I 2Class II 18Class III 0

plus 68 registration records and 55 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 2Class III 2Class IV 5

27 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States68 registration records, 55 510(k), 0 PMA, 5 excluded

Brazil1 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: VOLCANO CORPORATION · Volcano Corporation

FDA 510(k) clearances by year

52005

22006

22007

42008

12009

12010

22011

42012

82013

32014

102015

32016

32017

12018

22019

22020

22021

FDA listed device types

showing 8 of 20

Catheter, Peripheral, Atherectomy 1Mixer, Breathing Gases, Anesthesia Inhalation 1Detector And Alarm, Arrhythmia 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Wire, Guide, Catheter 1Drape, Surgical, Antimicrobial 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210235	Verrata PLUS Pressure Guide Wire	2021-04-15
US	K203719	IntraSight Mobile	2021-01-19
US	K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	2020-09-28
BR	10216719031	Plataforma para Aplicações de Intervenção IntraSight - Sistema Vascula	Class II
CA	9367	WAVEMAP SYSTEM	Class IV
CA	34209	TRAK BACK II	Class II
CA	36334	IN VISION GOLD IMAGING SYSTEM	Class III

VOLCANO CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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