Submission Details
| 510(k) Number | K163513 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2016 |
| Decision Date | February 24, 2017 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
Arrow Endurance Extended Dwell Peripheral Catheter System
Feb 2017
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K163513 is an FDA 510(k) clearance for the Arrow Endurance Extended Dwell Peripheral Catheter System, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on February 24, 2017, 71 days after receiving the submission on December 15, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA · US
Fallon Young
8 submissions
7 cleared
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