VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
FDA 510(k) clearance K100739 · decided 2010-12-07
Clearance details
- K-number
- K100739
- Device name
- VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-03-16
- Decision date
- 2010-12-07
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- KRB
- Device class
- 2
- Regulation number
- 870.1915
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.