ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA 510(k) clearance K050577 · decided 2005-03-30
Clearance details
- K-number
- K050577
- Device name
- ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-03-07
- Decision date
- 2005-03-30
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / recall (Z-2418-2011) | Boston Scientific Corporation | 2011-06-10 |
| Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 13 recall (Z-2419-2011) | Boston Scientific Corporation | 2011-06-10 |