ACUITY PRO LEAD DELIVERY SYSTEM
FDA 510(k) clearance K132914 · decided 2014-04-03
Clearance details
- K-number
- K132914
- Device name
- ACUITY PRO LEAD DELIVERY SYSTEM
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2013-09-17
- Decision date
- 2014-04-03
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, recall (Z-0588-2016) | Boston Scientific Corporation | 2016-01-05 |