510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010399Substantially Equivalent

Diatek Cannon-Cath #Cc2400, Cc2800, Cc3200, Cc3600,cc5500. Cc2400pc, Cc2800pc, Cc3200pc(32 Cm), Cc3200pc(36 Cm)

Diatek, Inc., Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010399 is the FDA 510(k) clearance record for DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM), a class II device, cleared for Diatek, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 15 510(k) clearances for Diatek, Inc., from to . As of , FDA records show 2 recalls naming K010399.

Clearance record

Decision date
Received
(186 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Diatek, Inc. 101 N. Chestnut St. #300, Winston-Salem NC
510(k) summary
Summary
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

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