DeviceClearance

ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS— 510(k) K113277

Substantially Equivalent

Arrow International, Inc.

FDA 510(k) clearance K113277 for ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS, Substantially Equivalent on 2012-06-21. Applicant: Arrow International, Inc.. Device class: 2.

Clearance details

Applicant
Arrow International, Inc.
Product code
Code LJS
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Reading, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LJS

view all

More clearances from Arrow International, Inc.

view all

Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

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

Recalls naming K113277

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113277.

Data sourced from openFDA. This site is unofficial and independent of the FDA.