Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro CATHETER,90
FDA 510(k) K042187 · Micro Therapeutics, Inc.
510(k) numberK042187
Submission
- Device name
- Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro CATHETER,90
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- August 12, 2004
- Decision date
- September 2, 2004
- 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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| K051990 | Echelon Micro CatheterKRA · Traditional | 01/04/2006SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | 06/28/2005SE |
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Questions and answers
When was Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro CATHETER,90 cleared by the FDA?
Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro CATHETER,90 (K042187) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 21 days after the submission was received.
What is the product code of K042187?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.