Arrow Endurance Extended Dwell Peripheral Catheter System
FDA 510(k) K152272 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
510(k) numberK152272
Submission
- Device name
- Arrow Endurance Extended Dwell Peripheral Catheter System
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA, US - Received
- August 12, 2015
- Decision date
- November 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K180395 | EZ-IO Intraosseous Vascular Access SystemFMI · Traditional | 11/09/2018SE |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter SystemFOZ · Special | 02/24/2017SE |
| K161765 | CG+ Arrow JACCLJS · Special | 09/06/2016SE |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…PND · Traditional | 08/24/2016SE |
| K160018 | Arrow Quickflash Arterial Catheterization DeviceDQX · Traditional | 06/13/2016SE |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSLJS · Special | 02/04/2016SE |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCLJS · Special | 01/28/2016SE |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsNIE · Traditional | 07/24/2015SEKD |
| K123759 | Cg+ Arrow Picc Powered by Arrow VPS StyletLJS · Special | 01/03/2013SE |
Questions and answers
When was Arrow Endurance Extended Dwell Peripheral Catheter System cleared by the FDA?
Arrow Endurance Extended Dwell Peripheral Catheter System (K152272) received a 510(k) decision of Substantially Equivalent on November 23, 2015, 103 days after the submission was received.
What is the product code of K152272?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.