Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter
FDA 510(k) K993691 · Arrow Intl., Inc.
510(k) numberK993691
Submission
- Device name
- Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- November 1, 1999
- Decision date
- March 8, 2000
- 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 |
|---|---|---|
| K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model:…LJS · Traditional | 08/27/2010SE |
| K093050 | Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520DQY · Special | 12/18/2009SE |
| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
| K071998 | Arrow Echogenic Introducer Needle ComponentFMI · Special | 09/26/2007SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | 07/17/2007SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | 05/06/2004SE |
| K040802 | Hemosonic 200HEMODYNAMIC MonitorDPN · Special | 04/28/2004SE |
Questions and answers
When was Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter cleared by the FDA?
Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter (K993691) received a 510(k) decision of Substantially Equivalent on March 8, 2000, 128 days after the submission was received.
What is the product code of K993691?
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.