Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA, US
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) appears in FDA device records in Reading, PA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Arrow International, Inc. (Subsidiary of Teleflex, Inc.) between 2013 and 2018. The busiest year on record is 2016, with 5. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180395 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | |
| K161765 | CG+ Arrow JACC | LJS | Substantially Equivalent | |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | PND | Substantially Equivalent | |
| K160018 | Arrow Quickflash Arterial Catheterization Device | DQX | Substantially Equivalent | |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | LJS | Substantially Equivalent | |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | LJS | Substantially Equivalent | |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | NIE | Unknown | |
| K123759 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain