510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182443Substantially Equivalent

Pristine Hemodialysis Catheter

Pristine Access Technologies, Ltd., Tel-Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182443 is the FDA 510(k) clearance record for Pristine Hemodialysis Catheter, a class II device, cleared for Pristine Access Technologies , Ltd. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list one 510(k) clearance for Pristine Access Technologies , Ltd. As of , FDA records show no recalls naming K182443.

Clearance record

Decision date
Received
(266 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pristine Access Technologies , Ltd. 21(B) Habarzel St., Tel-Aviv, IL
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