DeviceClearance

ARROW POSITIVE PLACEMENT CON/EPIDURAL AN— 510(k) K801912

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K801912 for ARROW POSITIVE PLACEMENT CON/EPIDURAL AN, Substantially Equivalent on 1980-09-16. Applicant: Arrow Intl., Inc.. Device class: 2.

Clearance details

Applicant
Arrow Intl., Inc.
Product code
Code CAZ
Device class
Class 2
Regulation
21 CFR 868.5140
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAZ

product code CAZ
Injury
145
Malfunction
942
Other
1
Total
1,088

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 K801912

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 K801912.

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