510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213602Substantially Equivalent

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

Medtronic, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213602 is the FDA 510(k) clearance record for Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit, a class II device, cleared for Covidien, LLC on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K213602.

Clearance record

Decision date
Received
(60 days to decision)
Product code
FJS Catheter, Peritoneal, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien, LLC 15 Hampshore St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FJS

Trailing 12 months

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

FDA records show no clearances under product code FJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJS, 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