OPTIBOLUS
FDA 510(k) clearance K031339 · decided 2003-07-11
Clearance details
- K-number
- K031339
- Device name
- OPTIBOLUS
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- Decision
- Substantially Equivalent
- Date received
- 2003-04-28
- Decision date
- 2003-07-11
- Days to decision
- 74 days
- Clearance type
- Special
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media deliver recall (Z-1828-2008) | Mallinckrodt Inc | 2008-09-03 |