510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991431Substantially Equivalent

14 Fr. Hemodialysis Two-Lumen Catheterization Kit

Arrow Intl., Inc., Reading PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K991431 is the FDA 510(k) clearance record for 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT, a class II device, cleared for Arrow Intl., Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show one recall naming K991431.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Arrow Intl., Inc. 2400 Bernville Rd., Reading PA
510(k) summary
Summary
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