Arrow Epidural Catheter Kit— 510(k) K161075

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K161075 for Arrow Epidural Catheter Kit, Substantially Equivalent on 2016-10-04. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2016-04-18
Decision date: 2016-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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 →

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