FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
FDA 510(k) clearance K061210 · decided 2006-06-27
Clearance details
- K-number
- K061210
- Device name
- FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
- Applicant
- Kyphon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-01
- Decision date
- 2006-06-27
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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.