ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT— 510(k) K870572

Clearance details

Applicant

Arrow Intl., Inc.

Product code

Code JOL

Device class

Class 2

Regulation

21 CFR 880.6740

Advisory panel

General Hospital

Date received

1987-02-10

Decision date

1987-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reading, PA, US

• K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F80142005-08-12
• K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION2001-07-12
• K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION2001-07-12
• K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION2001-05-01
• K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP2000-10-25

• K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-455042010-08-27
• K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 005202009-12-18
• K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES2007-10-10
• K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT2007-09-26
• K071111 — NON-ABSORBABLE SILK SUTURE2007-07-17

Death

7

Injury

177

Malfunction

1,306

Other

1

Total

1,491

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1966-2018 — Maximal Barrier Drape; Product Code: ASK-01000-UPMSClass II·Terminated·Arrow International Inc·20180411
• Z-1298-2018 — ArrowClarke" PleuraSeal¿ Thoracentesis KitClass II·Terminated·Arrow International Inc·20171024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K870572.