Submission Details
| 510(k) Number | K152272 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2015 |
| Decision Date | November 23, 2015 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Arrow Endurance Extended Dwell Peripheral Catheter System
Nov 2015
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K152272 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 November 23, 2015, 103 days after receiving the submission on August 12, 2015. 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
TRACY LARISH
8 submissions
7 cleared
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