Home›USA›Abbott Vascular, Inc.

Abbott Vascular, Inc.

USA · Santa Clara

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

40listed device types

Class I 4Class II 24Class III 11unclassified 1

plus 326 registration records and 64 510(k), 930 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 3Class II 3

17 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

58active device licences

Class II 18Class III 4Class IV 36

118 including historic records

TWTaiwanTFDA

46valid device licences

Class II 31Class III 15

SGSingaporeHSA SMDR

11device registrations

CLASS B 4CLASS C 2CLASS D 5

KRSouth KoreaMFDS GMP

12GMP quality-system certificates

Import 12

AUAustraliaTGA ARTG

19active ARTG entries

Class I 1Class III 12IIa 4Class Is (sterile) 2

HKHong KongMDACS

16valid listings

Class II 4Class III 2Class IV 10

ILIsraelAMAR

33registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 1Class 3 2

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 States326 registration records, 64 510(k), 930 PMA, 60 excluded

Brazil6 confirmed, 29 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada58 confirmed, 25 excluded

Manufacturer names merged into this page: ABBOTT VASCULAR · Abbott Vascular Netherlands · Abbott Vascular · ABBOTT LABORATORIES, ABBOTT VASCULAR INC. · ABBOTT IRELAND VASCULAR DIVISION · ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH

FDA 510(k) clearances by year

22001

22002

22003

22005

12006

22007

72008

82009

52010

72011

52012

22013

32014

42015

12016

22017

22018

22019

22020

22022

FDA listed device types

showing 8 of 40

Bottle, Collection, Vacuum 1Catheter, Intravascular, Diagnostic 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Transducer, Pressure, Catheter Tip 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Syringe, Balloon Inflation 1Catheter, Angioplasty, Peripheral, Transluminal 1Computer, Diagnostic, Programmable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220634	NC TREK NEO Coronary Dilatation Catheter	2022-06-30
US	K221057	Viatrac 14 Plus Peripheral Dilatation Catheter	2022-05-05
US	K201834	HI-TORQUE PROCEED Guide Wire Family	2020-07-30
BR	80146509042	STABILIZER	Class I
BR	80146509040	SUPPORT PLATE	Class I
BR	80146501771	H-I TORQUE VERSACORE 035 GUIDE WIRE	Class II
CA	68139	SUTURE TRIMMERS	Class IV
CA	11181	KNOT PUSHER	Class II
CA	14494	HEARTFLO ANASTOMOSIS DEVICE (MECHANICALLY DRIVEN)	Class IV