510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQKClass II

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

21 CFR 870.1252 / Cardiovascular
FDA source (opens on fda.gov)

PQK is the FDA product code for Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access, a class II device type, regulated under 21 CFR 870.1252. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PQK
Device name
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
FDA definition
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.
Regulation
21 CFR 870.1252
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code PQK

By decision year
7 clearances under product code PQK with a decision year between 2018 and 2019, 2019 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PQK by decision year
YearClearances
20183
20194

Applicants with the most clearances

Product code PQK
Applicants holding the most 510(k) clearances under product code PQK
ApplicantClearances
Avenu Medical, Inc.4
C.R. Bard Inc2
Tva Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code