Company ยท US
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2022. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 8 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
| PND | Midline Catheter | 2 |
| DQX | Wire, Guide, Catheter | 1 |
| DYB | Introducer, Catheter | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2022 | K213855 | Arrow Pressure Injectable Midline Catheter Arrow International, LLC Subsidiary of Teleflex Incorporated | PND |
| Nov 9, 2018 | K180395 | EZ-IO Intraosseous Vascular Access System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FMI |
| Feb 24, 2017 | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ |
| Sep 6, 2016 | K161765 | CG+ Arrow JACC Arrow International, Inc. (Subsidiary of Teleflex | LJS |
| Aug 24, 2016 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | PND |
| Jun 13, 2016 | K160018 | Arrow Quickflash Arterial Catheterization Device Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | DQX |
| Feb 4, 2016 | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | LJS |
| Jan 28, 2016 | K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | LJS |
| Nov 23, 2015 | K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ |
| Jul 24, 2015 | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | NIE |
| Sep 26, 2013 | K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | OBJ |
| Jan 4, 2013 | K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER Arrow International (Subsidiary of Teleflex Inc.) | DYB |
| Jan 3, 2013 | K123759 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. (Subsidiary of Teleflex | LJS |
| Nov 29, 2012 | K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| Sep 20, 2012 | K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| Sep 7, 2012 | K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | LJS |
| May 10, 2012 | K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.) | LJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||