MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
FDA 510(k) clearance K030141 · decided 2003-02-26
Clearance details
- K-number
- K030141
- Device name
- MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
- Applicant
- Cardiovention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-15
- Decision date
- 2003-02-26
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.