AC3 Series IABP System
FDA 510(k) clearance K162820 · decided 2017-03-31
Clearance details
- K-number
- K162820
- Device name
- AC3 Series IABP System
- Applicant
- Arrow International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-07
- Decision date
- 2017-03-31
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-070 recall (Z-2416-2020) | Arrow International Inc | 2020-06-26 |
| Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-070 recall (Z-2417-2020) | Arrow International Inc | 2020-06-26 |