510(k) K042218
- Device
- ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
- Applicant
- GUIDANT CORP.
- 510(k) number
- K042218
- Product code
- NTE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-31
- Date received
- 2004-08-05
- Regulation
- 870.1250
- Classification name
- Temporary Carotid Catheter For Embolic Capture
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARAINE PANGELINA
- Address
- 3200 Lakeside Dr. Santa Clara CA US 95054 95054
FDA Registration Numbers#
- 3011471056
- 9617601
- 2183744
- 2134265
- 3007695959
- 2024024
- 2183870
- 3004091615
- 3012121095
- 2124215
- 3002806603
- 3002807314
- 1016427
- 1000121056
- 3007738736
- 2939561
- 2011171
- 3013666336
- 3004742232
- 1319639
- 3013944123
- 2126666
- 2024168
- 3022627847
- 3004859241
- 3013556777
Source Documents#
Other 510(k) Records For Product Code NTE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | 2023-04-27 |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023-04-11 |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | 2022-04-06 |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021-03-03 |
| K200198 | WIRION | Cardiovascular Systems, Inc. | 2020-03-18 |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | 2019-07-25 |
| K180023 | WIRION | Gardia Medical , Ltd. | 2018-03-21 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016-03-10 |
| K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | 2015-11-20 |
| K143570 | WIRION | Gardia Medical | 2015-06-04 |
| K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015-02-09 |
| K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2014-07-22 |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | 2012-12-13 |
| K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2012-05-04 |
| K120480 | GORE(R) EMBOLIC FILTER | W.L. Gore & Associates | 2012-03-16 |
Legacy Summary#
summary
FDA Review#
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