Submission Details
| 510(k) Number | K180395 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 13, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
EZ-IO Intraosseous Vascular Access System
Nov 2018
Decision
269d
Days
Class 2
Risk
About This 510(k) Submission
K180395 is an FDA 510(k) clearance for the EZ-IO Intraosseous Vascular Access System, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on November 9, 2018, 269 days after receiving the submission on February 13, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA · US
Frank Pelc
8 submissions
7 cleared
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