Micrus Ascent Occlusion Balloon Catheter
FDA 510(k) K080861 · Micrus Endovascular Corporation
510(k) numberK080861
Submission
- Device name
- Micrus Ascent Occlusion Balloon Catheter
- Applicant
- Micrus Endovascular Corporation
San Jose, CA, US - Received
- March 27, 2008
- Decision date
- August 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…MJN · Special | 01/26/2011SE |
| K102818 | Micrus One 2 One Guidewire, Micrus One 2 One Soft GuidewireDQX · Special | 12/03/2010SE |
| K092702 | Micrus Microcatheter, Model Courier 270DQO · Special | 11/20/2009SE |
| K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…MJN · Special | 06/19/2009SE |
| K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00DQO · Special | 05/06/2009SE |
| K090274 | Micrus One 2 One Guidewire and Soft GuidewireDQX · Special | 03/03/2009SE |
| K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPLHCG · Special | 01/02/2009SE |
| K082739 | Micrus Microcoil Delivery SystemHCG · Special | 10/17/2008SE |
| K080379 | Micrus Microcoil System, Deltapaq 10 Stretch ResistantHCG · Traditional | 06/30/2008SE |
| K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFHCG · Traditional | 05/08/2008SE |
Questions and answers
When was Micrus Ascent Occlusion Balloon Catheter cleared by the FDA?
Micrus Ascent Occlusion Balloon Catheter (K080861) received a 510(k) decision of Substantially Equivalent on August 27, 2008, 153 days after the submission was received.
What is the product code of K080861?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.