AC3 Series IABP System— 510(k) K162820
Substantially EquivalentArrow International, Inc.
FDA 510(k) clearance K162820 for AC3 Series IABP System, Substantially Equivalent on 2017-03-31. 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
- Traditional
- 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 K162820
K-number listed on FDA's recall record- Z-2416-2020 — Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
- Z-2417-2020 — Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162820.
Data sourced from openFDA. This site is unofficial and independent of the FDA.