SPIDERX EMBOLIC PROTECTION DEVICE— 510(k) K062201
Substantially EquivalentEv3, Inc.
FDA 510(k) clearance K062201 for SPIDERX EMBOLIC PROTECTION DEVICE, Substantially Equivalent on 2006-08-11. Applicant: Ev3, Inc.. Device class: 2.
Clearance details
- Applicant
- Ev3, Inc.
- Product code
- Code NFA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.