Arrow Stiffening Stylet— 510(k) K220280

Name: FDA 510(k) clearance K220280
Creator: U.S. Food and Drug Administration
Published: 2022-08-30

Substantially Equivalent

Arrow International, LLC (A subsidiary of Teleflex, Inc.)

FDA 510(k) clearance K220280 for Arrow Stiffening Stylet, Substantially Equivalent on 2022-08-30. Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Device class: 2.

Clearance details

Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
Advisory panel: Cardiovascular
Date received: 2022-02-01
Decision date: 2022-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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K182660 — GaltTWS2019-05-30
K170298 — Liberator Beacon Tip Locking Stylet2017-10-18
K142116 — LLD EZ2014-08-12
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Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.