Submission Details
| 510(k) Number | K160018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 05, 2016 |
| Decision Date | June 13, 2016 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Arrow Quickflash Arterial Catheterization Device
Jun 2016
Decision
160d
Days
Class 2
Risk
About This 510(k) Submission
K160018 is an FDA 510(k) clearance for the Arrow Quickflash Arterial Catheterization Device, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on June 13, 2016, 160 days after receiving the submission on January 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA · US
TRACY LARISH
8 submissions
7 cleared
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