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Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

FDA product code PQK · 5 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1252
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-10-05 – 2019-10-17

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

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