OPTISTAR MR INJECTOR SYSTEM
FDA 510(k) clearance K984088 · decided 1999-12-06
Clearance details
- K-number
- K984088
- Device name
- OPTISTAR MR INJECTOR SYSTEM
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- Decision
- Substantially Equivalent
- Date received
- 1998-11-16
- Decision date
- 1999-12-06
- Days to decision
- 385 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati recall (Z-1118-2012) | Mallinckrodt Inc | 2012-02-29 |
| Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati recall (Z-1119-2012) | Mallinckrodt Inc | 2012-02-29 |
| Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company recall (Z-1120-2012) | Mallinckrodt Inc | 2012-02-29 |
| Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company recall (Z-1121-2012) | Mallinckrodt Inc | 2012-02-29 |
| Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Compa recall (Z-1122-2012) | Mallinckrodt Inc | 2012-02-29 |