HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
FDA 510(k) clearance K091458 · decided 2009-10-15
Clearance details
- K-number
- K091458
- Device name
- HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
- Applicant
- Ev3 Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2009-10-15
- Days to decision
- 150 days
- Clearance type
- Traditional
- 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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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Onyx Liquid Embolic System (LES) (P030004/S035) | Ev3 Neurovascular | 2025-12-08 |
| Apollo Onyx Delivery Micro Catheter (P030004/S037) | Ev3 Neurovascular | 2024-12-19 |
| Apollo Onyx Delivery Micro Catheter (P030004/S036) | Ev3 Neurovascular | 2024-11-07 |
| Apollo Onyx Delivery Micro Catheter (P030004/S034) | Ev3 Neurovascular | 2024-09-20 |
| Onyx Liquid Embolic System (P030004/S033) | Ev3 Neurovascular | 2024-07-26 |
| Apollo Onyx Delivery Micro Catheter 1.5 cm, Apollo Onyx Delivery Micro Catheter 3.0 cm (P030004/S031) | Ev3 Neurovascular | 2024-04-16 |
| Onyx Liquid Embolic System (P030004/S030) | Ev3 Neurovascular | 2023-11-03 |
| Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm (P030004/S029) | Ev3 Neurovascular | 2022-07-28 |