ANGIOMAT ILLUMENA
FDA 510(k) clearance K963071 · decided 1997-09-23
Clearance details
- K-number
- K963071
- Device name
- ANGIOMAT ILLUMENA
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- Decision
- Substantially Equivalent
- Date received
- 1996-08-07
- Decision date
- 1997-09-23
- Days to decision
- 412 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 |
|---|---|---|
| Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in recall (Z-2859-2011) | Mallinckrodt Inc | 2011-07-21 |
| Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. recall (Z-0056-2008) | Mallinckrodt Inc | 2007-10-13 |