510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233515Substantially Equivalent

Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Nuwellis, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233515 is the FDA 510(k) clearance record for Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102), a class II device, cleared for Nuwellis, Inc. on under FDA product code NQJ (Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use). FDA's definition for product code NQJ 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". FDA records list 2 510(k) clearances for Nuwellis, Inc., from to . As of , FDA records show no recalls naming K233515.

Clearance record

Decision date
Received
(55 days to decision)
Product code
NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nuwellis, Inc. 12988 Valley View Rd., Eden Prairie MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQJ

Trailing 12 months

FDA records hold no clearances under product code NQJ in the trailing twelve months.

FDA records show no clearances under product code NQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260