510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K870572Substantially Equivalent

Arrow-Clarke(tm) Pleura-Seal(tm) Thoracentesis Kit

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

K870572 is the FDA 510(k) clearance record for ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT, a class II device, cleared for Arrow Intl., Inc. on under FDA product code JOL (Catheter And Tip, Suction). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show 2 recalls naming K870572.

Clearance record

Decision date
Received
(105 days to decision)
Product code
JOL Catheter And Tip, Suction
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Arrow Intl., Inc. P.O. Box 6306, Reading PA
Third party review
No

Clearances, product code JOL

Trailing 12 months

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

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