HYPERGLIDE OCCLUSION BALLOON SYSTEM
FDA 510(k) clearance K090728 · decided 2009-04-16
Clearance details
- K-number
- K090728
- Device name
- HYPERGLIDE OCCLUSION BALLOON SYSTEM
- Applicant
- Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-19
- Decision date
- 2009-04-16
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
| AortaSTAT Occlusion Device (K210602) | Renalpro Medical, Inc. | 2021-07-09 |
| Neurescue device (K210358) | Neurescue Aps | 2021-05-21 |
| COBRA-OS Kit (K201652) | Front Line Medical Technologies, Inc. | 2021-02-22 |
| Bridge Occlusion Balloon (K203540) | Spectranetics, Inc. | 2020-12-23 |
| pREBOA-PRO Catheter (K200459) | Prytime Medical Devices, Inc. | 2020-06-03 |
| Gatekeeper Balloon Catheter (K192786) | Arch Catheter, LLC | 2020-04-25 |
Recalls involving this device
No recalls on record reference this clearance.