Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo
FDA 510(k) K001237 · Micro Therapeutics, Inc.
510(k) numberK001237
Submission
- Device name
- Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- April 18, 2000
- Decision date
- May 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJN – Catheter, Intravascular Occluding, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code MJN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243795 | pREBOA-PRO CatheterMJN · Traditional | Prytime Medical Devices, Inc. | 09/05/2025SE |
| K251358 | Bridge Plus Occlusion Balloon (590-002)MJN · Traditional | Philips Image Guided Therapy Devices | 06/24/2025SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | Abiomed, Inc. | 06/30/2023SESU |
| K214060 | LANDMARK REBOA CatheterMJN · Traditional | Zien Medical Technologies, Inc. | 09/19/2022SE |
| K211610 | Fogarty Occlusion CatheterMJN · Traditional | Edwards Lifesciences, LLC | 02/14/2022SE |
| K212324 | RenovoCathMJN · Special | Renovorx, Inc. | 08/23/2021SE |
| K210602 | AortaSTAT Occlusion DeviceMJN · Traditional | Renalpro Medical, Inc. | 07/09/2021SE |
| K210358 | Neurescue deviceMJN · Traditional | Neurescue Aps | 05/21/2021SE |
| K201652 | COBRA-OS KitMJN · Traditional | Front Line Medical Technologies, Inc. | 02/22/2021SESK |
| K203540 | Bridge Occlusion BalloonMJN · Special | Spectranetics, Inc. | 12/23/2020SE |
More from Spectranetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113289 | Orion Micro CatheterKRA · Traditional | 08/01/2012SE |
| K113454 | 14 Wire Standard, 14 Wire LSDQX · Traditional | 02/24/2012SE |
| K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…KRA · Special | 05/01/2009SE |
| K090046 | Concerto Detachable Coil SystemKRD · Special | 02/27/2009SE |
| K081465 | Axium Detachable Coil SystemKRD · Traditional | 08/19/2008SE |
| K060747 | FX Detachable Coil SystemHCG · Traditional | 04/24/2007SE |
| K060625 | Nexus Detachable Coil System, Morpheus 3D CSRHCG · Special | 04/20/2006SE |
| K051990 | Echelon Micro CatheterKRA · Traditional | 01/04/2006SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | 06/28/2005SE |
| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | 06/22/2005SE |
Questions and answers
When was Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo cleared by the FDA?
Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo (K001237) received a 510(k) decision of Substantially Equivalent on May 18, 2000, 30 days after the submission was received.
What is the product code of K001237?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.