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Device
catheter, angioplasty, peripheral, transluminal
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Product Code
LIT
Premarket Review
Coronary and Peripheral Interventional Devices
(DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type
510(k)
Regulation Number
870.1250
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
3-172 AAMI TIR42:2021
Evaluation of Particulates Associated with Vascular Medical Devices
3-176 ISO 18193 First edition 2021-08
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
3-183 ISO 11658 First edition 2012-05-15
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
6-322 ISO 10555-4 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
6-408 ISO 10555-1 Second edition 2013-06-15
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
Third Party Review
Eligible for
510(k) Third Party Review Program
Accredited Persons
global quality and regulatory services
regulatory technology services, llc
sgs north america
third party review group, llc
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