LBI CATHETER SYSTEM
FDA 510(k) clearance K053372 · decided 2006-06-30
Clearance details
- K-number
- K053372
- Device name
- LBI CATHETER SYSTEM
- Applicant
- Lumen Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-05
- Decision date
- 2006-06-30
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.