Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba
FDA 510(k) K093750 · Ev3, Inc.
510(k) numberK093750
Submission
- Device name
- Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba
- Applicant
- Ev3, Inc.
Irvine, CA, US - Received
- December 7, 2009
- Decision date
- December 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | Boston Scientific Corporation | 05/15/2026SE |
| K250794 | InVera Infusion DeviceKRA · Traditional | Invera Medical | 03/12/2026SE |
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| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional | Transit Scientific, LLC | 11/29/2023SE |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | Wallaby Medical | 04/25/2023SE |
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Questions and answers
When was Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba cleared by the FDA?
Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba (K093750) received a 510(k) decision of Substantially Equivalent on December 9, 2009, 2 days after the submission was received.
What is the product code of K093750?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.