Submission Details
| 510(k) Number | K220280 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2022 |
| Decision Date | August 30, 2022 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Arrow Stiffening Stylet
Aug 2022
Decision
210d
Days
Class 2
Risk
About This 510(k) Submission
K220280 is an FDA 510(k) clearance for the Arrow Stiffening Stylet, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on August 30, 2022, 210 days after receiving the submission on February 1, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.
Device Classification
| Product Code | DRB — Stylet, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1380 |
Manufacturer
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Morrisville, NC · US
Fallon Young
4 submissions
4 cleared
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