EQUALIZER BALLOON CATHETER
FDA 510(k) clearance K021721 · decided 2002-06-20
Clearance details
- K-number
- K021721
- Device name
- EQUALIZER BALLOON CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-05-24
- Decision date
- 2002-06-20
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- 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 Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/ recall (Z-0194-2010) | Boston Scientific Corporation | 2009-11-13 |
| Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/ recall (Z-0195-2010) | Boston Scientific Corporation | 2009-11-13 |
| Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/ recall (Z-0196-2010) | Boston Scientific Corporation | 2009-11-13 |
| Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/ recall (Z-0197-2010) | Boston Scientific Corporation | 2009-11-13 |