RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
FDA 510(k) clearance K042908 · decided 2004-11-12
Clearance details
- K-number
- K042908
- Device name
- RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-21
- Decision date
- 2004-11-12
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| ENROUTE® Transcarotid Neuroprotection System (K230402) | Silk Road Medical | 2023-04-11 |
| ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (K220654) | Cordis Corporation | 2022-04-06 |
| WIRION Embolic Protection System (K210282) | Cardiovascular Systems, Inc. | 2021-03-03 |
| WIRION (K200198) | Cardiovascular Systems, Inc. | 2020-03-18 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| WIRION (K180023) | Gardia Medical , Ltd. | 2018-03-21 |
| ENROUTE Transcarotid Neuroprotection System (K153485) | Silk Road Medical, Inc. | 2016-03-10 |
| RX ACCUNET Embolic Protection System (K153086) | Abbott Vascular | 2015-11-20 |
| WIRION (K143570) | Gardia Medical | 2015-06-04 |
| ENROUTE Transcarotid Neuroprotection System (K143072) | Silk Road Medical, Inc. | 2015-02-09 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K141678) | Abbott Vascular | 2014-07-22 |
Recalls involving this device
No recalls on record reference this clearance.