Hyperglide Occlusion Balloon System
FDA 510(k) K090728 · Ev3, Inc.
510(k) numberK090728
Submission
- Device name
- Hyperglide Occlusion Balloon System
- Applicant
- Ev3, Inc.
Irvine, CA, US - Received
- March 19, 2009
- Decision date
- April 16, 2009
- 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 |
|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | 01/05/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
Questions and answers
When was Hyperglide Occlusion Balloon System cleared by the FDA?
Hyperglide Occlusion Balloon System (K090728) received a 510(k) decision of Substantially Equivalent on April 16, 2009, 28 days after the submission was received.
What is the product code of K090728?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.