IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k) clearance K050863 · decided 2005-09-02
Clearance details
- K-number
- K050863
- Device name
- IMAGER II ANGIOGRAPHIC CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-04-05
- Decision date
- 2005-09-02
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Ma recall (Z-1394-2012) | Boston Scientific Corporation | 2012-04-11 |
| Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Bo recall (Z-0336-2010) | Boston Scientific Corporation | 2010-01-21 |
| Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, recall (Z-0279-2008) | Boston Scientific Corporation | 2007-12-06 |