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

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NQJ is the FDA product code for Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NQJ
Device name
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
FDA definition
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code NQJ

By decision year
4 clearances under product code NQJ with a decision year between 2003 and 2025, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NQJ by decision year
YearClearances
20031
20041
20231
20251

Applicants with the most clearances

Product code NQJ
Applicants holding the most 510(k) clearances under product code NQJ
ApplicantClearances
Chf Solutions, Inc.2
Nuwellis, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code