510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K022221Unknown

Truflow Long-Term and Short-Term Dual-Lumen Dialysis Catheters

Abbott Medical, St. Paul MN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022221 is the FDA 510(k) clearance record for TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS, a class II device, cleared for Deltec, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K022221.

Clearance record

Decision date
Received
(205 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Deltec, Inc. 1265 Grey Fox Rd., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPB

Trailing 12 months

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

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