AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP— 510(k) K201112
Substantially EquivalentArrow International, Inc.
FDA 510(k) clearance K201112 for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP, Substantially Equivalent on 2020-05-27. Applicant: Arrow International, Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow International, Inc.
- Product code
- Code DSP
- Device class
- Class 2
- Regulation
- 21 CFR 870.3535
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chelmsford, MA, US
Recent devices under product code DSP
view allMore clearances from Arrow International, Inc.
view allAdverse events under product code DSP
product code DSP- Death
- 317
- Injury
- 566
- Malfunction
- 36,831
- Other
- 4
- Total
- 37,718
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201112
K-number listed on FDA's recall record- Z-0433-2023 — Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
- Z-0434-2023 — Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
- Z-0435-2023 — Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
- Z-0436-2023 — Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
- Z-0437-2023 — Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
- Z-0438-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
- Z-0439-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
- Z-0440-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
- Z-0441-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
- Z-0442-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
- Z-0443-2023 — Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201112.
Data sourced from openFDA. This site is unofficial and independent of the FDA.