EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
FDA 510(k) clearance K073473 · decided 2008-01-14
Clearance details
- K-number
- K073473
- Device name
- EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-12-11
- Decision date
- 2008-01-14
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rancho Cordova,, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.