510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K140884Unknown

Symetrex Long Term Hemodialysis Catheter

Phase One Medical, Great Neck NY / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140884 is the FDA 510(k) clearance record for SYMETREX LONG TERM HEMODIALYSIS CATHETER, a class II device, cleared for Phase One Medical on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list one 510(k) clearance for Phase One Medical. As of , FDA records show no recalls naming K140884.

Clearance record

Decision date
Received
(233 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Phase One Medical 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
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