Spiderx Embolic Protection Device
FDA 510(k) K062201 · Ev3, Inc.
510(k) numberK062201
Submission
- Device name
- Spiderx Embolic Protection Device
- Applicant
- Ev3, Inc.
Plymouth, MN, US - Received
- August 1, 2006
- Decision date
- August 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFA – Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code NFA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073523 | Interceptor Plus Coronary Filter SystemsNFA · Traditional | Medtronic, Inc. | 08/01/2008SE |
| K073563 | Modification to Proxis SystemNFA · Special | St Jude Medical | 01/31/2008SE |
| K063785 | Spiderfx Embolic Protection DeviceNFA · Special | Ev3, Inc. | 01/19/2007SE |
| K062870 | Triactiv FX Embolic Protection System, Model PN 60040-02; -03NFA · Special | Kensey Nash Corp. | 10/20/2006SE |
| K060651 | Proxis System, Model EPS101NFA · Traditional | St Jude Medical | 09/13/2006SE |
| K052523 | Proxis SystemNFA · Traditional | Velocimed, Inc. | 09/07/2006SE |
| K061332 | Filterwire Ez Embolic Protection System (2.25 MM-3.5 MM)NFA · Special | Boston Scientific Corp | 08/11/2006SE |
| K061772 | Triactiv FX Embolic Protection SystemNFA · Traditional | Kensey Nash Corp. | 07/11/2006SE |
| K053195 | Spiderx Embolic Protection DeviceNFA · Traditional | Ev3, Inc. | 06/23/2006SE |
| K051984 | Filterwire Ez (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300NFA · Traditional | Boston Scientific Corp | 04/10/2006SE |
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| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
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Questions and answers
When was Spiderx Embolic Protection Device cleared by the FDA?
Spiderx Embolic Protection Device (K062201) received a 510(k) decision of Substantially Equivalent on August 11, 2006, 10 days after the submission was received.
What is the product code of K062201?
The FDA product code is NFA – Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection, a Class II (moderate risk) device regulated under 21 CFR 870.1250.