Home›USA›Cardiovascular Systems Incorporated

Cardiovascular Systems Incorporated

USA · Saint Paul

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

35listed device types

Class I 6Class II 27Class III 2

plus 99 registration records and 228 510(k), 272 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

52active device licences

Class II 31Class III 11Class IV 10

85 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States99 registration records, 228 510(k), 272 PMA, 36 excluded

Brazil2 confirmed, 5 excluded

Canada52 confirmed, 7 excluded

Manufacturer names merged into this page: Cardiovascular Systems Incorporated · CARDIOVASCULAR SYSTEMS INCORPORATED · TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · TERUMO CARDIOVASCULAR SYSTEMS THI PLANT · GUIDANT ADVANCED CARDIOVASCULAR SYSTEMS INC. · TERUMO CARDIOVASCULAR SYSTEMS CORP.

FDA 510(k) clearances by year

22006

72007

52008

82009

22010

42011

42012

42013

82014

132015

22016

32017

62018

12019

22020

62021

12022

12023

12024

12025

FDA listed device types

showing 8 of 35

Electrosurgical, Cutting & Coagulation & Accessories 1Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Percutaneous 1Controller, Temperature, Cardiopulmonary Bypass 1Detector, Bubble, Cardiopulmonary Bypass 1Laparoscope, General & Plastic Surgery 1Reservoir, Blood, Cardiopulmonary Bypass 1Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250684	OPUSWAVE Dual Sensor Imaging System	2025-07-02
US	K234065	CDI OneView Monitoring System	2024-04-25
US	K221895	Terumo Advanced Perfusion System 1	2023-04-18
BR	80012280016	OXIGENADOR DE FIBRAS OCAS CAPIOX SX COM RESERVATORIO RIGIDO TERUMO	Class II
BR	80012280097	CUVETA H/S CDI TERUMO	Class II
CA	24421	ARTERIAL FILTERS WITH X-COATING	Class II
CA	25855	SARNS CENTRIFUGAL PUMP	Class III
CA	63930	CAPIOX FLEXIBLE VENOUS RESEVOIR	Class II

Cardiovascular Systems Incorporated

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies