ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set— 510(k) K153652

Substantially Equivalent

Teleflex, Inc.

FDA 510(k) clearance K153652 for ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set, Substantially Equivalent on 2016-06-21. Applicant: Teleflex, Inc.. Device class: 2.

Clearance details

Applicant
Teleflex, 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
Morrisville, NC, 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 →

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