XTRACT CATHETER SYSTEM
FDA 510(k) clearance K071529 · decided 2007-08-10
Clearance details
- K-number
- K071529
- Device name
- XTRACT CATHETER SYSTEM
- Applicant
- Lumen Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-05
- Decision date
- 2007-08-10
- Days to decision
- 66 days
- Clearance type
- Special
- 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
| Record | Firm | Date |
|---|---|---|
| Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of recall (Z-0445-2011) | Volcano Corporation | 2010-11-23 |