510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102833Substantially Equivalent

Disposable Hemodialysis Access Catheter Sets

Foshan Nanhai Bai HE Medical Technology Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102833 is the FDA 510(k) clearance record for DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS, a class II device, cleared for Foshan Nanhai Bai HE Medical Technology Co., Ltd. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 2 510(k) clearances for Foshan Nanhai Bai HE Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K102833.

Clearance record

Decision date
Received
(415 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Foshan Nanhai Bai HE Medical Technology Co., Ltd. P.O. Box 237-023, Shanghai, CN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPB, 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