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Product Classification

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Device

catheter, intravascular, therapeutic, long-term greater than 30 days

Regulation Medical Specialty

General Hospital

Review Panel

General Hospital

Product Code

LJS

Premarket Review

Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)

Submission Type

510(k)

Regulation Number

880.5970

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Eligible

Implanted Device?

Yes

Life-Sustain/Support Device?

No

Recognized Consensus Standards

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
6-273 ISO 23908 First edition 2011-06-11
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
6-305 ISO 10555-3 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous 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

Not Third Party Eligible

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