Accunet Embolic Protection System, RX Accunet Embolic Protection System
FDA 510(k) K042218 · Guidant Corp.
Submission
- Device name
- Accunet Embolic Protection System, RX Accunet Embolic Protection System
- Applicant
- Guidant Corp.
Santa Clara, CA, US - Received
- August 5, 2004
- Decision date
- August 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic…
Other 510(k)s with product code NTE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | MicroVention, Inc. | 04/27/2023SE |
| K230402 | ENROUTE® Transcarotid Neuroprotection SystemNTE · Special | Silk Road Medical | 04/11/2023SE |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | Cordis Corporation | 04/06/2022SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | Cardiovascular Systems, Inc. | 03/03/2021SE |
| K200198 | WirionNTE · Traditional | Cardiovascular Systems, Inc. | 03/18/2020SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | Abbott Vascular | 07/25/2019SE |
| K180023 | WirionNTE · Traditional | Gardia Medical , Ltd. | 03/21/2018SE |
| K153485 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 03/10/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | Abbott Vascular | 11/20/2015SE |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
More from Gardia Medical
| 510(k) | Device | Decision |
|---|---|---|
| K061865 | Flex 10 Mis Ablation Probe, Model FLX10MI-05NEY · Special | 07/27/2006SE |
| K061453 | Hi-Torque Whisper View Guide WireDQX · Special | 06/22/2006SE |
| K060449 | Hi-Torque Advance and Advance Lite Guide WireDQX · Traditional | 05/30/2006SE |
| K053459 | Omnilink .035 Biliary Stent SystemFGE · Traditional | 04/12/2006SESU |
| K053454 | RX Herculink Elite Biliary Stent SystemFGE · Traditional | 03/06/2006SESU |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | 02/13/2006SE |
| K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000GEI · Special | 09/21/2005SE |
| K052166 | Modification to: RX Accunet Embolic Protection SystemNTE · Special | 08/18/2005SE |
| K052165 | RX Accunet Embolic Protection SystemNTE · Special | 08/16/2005SE |
Questions and answers
When was Accunet Embolic Protection System, RX Accunet Embolic Protection System cleared by the FDA?
Accunet Embolic Protection System, RX Accunet Embolic Protection System (K042218) received a 510(k) decision of Substantially Equivalent on August 31, 2004, 26 days after the submission was received.
What is the product code of K042218?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.