RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2— 510(k) K041705
Substantially EquivalentOmnisonics Medical Technologies
FDA 510(k) clearance K041705 for RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2, Substantially Equivalent on 2004-09-01. Applicant: Omnisonics Medical Technologies. Device class: 2.
Clearance details
- Applicant
- Omnisonics Medical Technologies
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
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More clearances from Omnisonics Medical Technologies
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