DeviceClearance

ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER— 510(k) K993691

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K993691 for ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER, Substantially Equivalent on 2000-03-08. Applicant: Arrow Intl., Inc.. Device class: 2.

Clearance details

Applicant
Arrow Intl., Inc.
Product code
Code FOZ
Device class
Class 2
Regulation
21 CFR 880.5200
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 FOZ

view all

More clearances from Arrow Intl., Inc.

view all

Adverse events under product code FOZ

product code FOZ
Death
38
Injury
2,290
Malfunction
25,858
Other
11
Total
28,197

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 K993691

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 K993691.

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