AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
FDA 510(k) clearance K090914 · decided 2009-07-16
Clearance details
- K-number
- K090914
- Device name
- AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
- Applicant
- Xoft, Inc.
- Decision
- Unknown
- Date received
- 2009-04-01
- Decision date
- 2009-07-16
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.