AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
FDA 510(k) clearance K201112 · decided 2020-05-27
Clearance details
- K-number
- K201112
- Device name
- AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
- Applicant
- Arrow International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-27
- Decision date
- 2020-05-27
- Days to decision
- 30 days
- Clearance type
- Special
- 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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