CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System— 510(k) K222038
Substantially EquivalentAbbott (Formerly Thoratec Corporation)
FDA 510(k) clearance K222038 for CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System, Substantially Equivalent on 2022-12-08. Applicant: Abbott (Formerly Thoratec Corporation). Device class: 2.
Clearance details
- Applicant
- Abbott (Formerly Thoratec Corporation)
- Product code
- Code QNR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code QNR
view allMore clearances from Abbott (Formerly Thoratec Corporation)
view allAdverse events under product code QNR
product code QNR- Death
- 11
- Total
- 11
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 K222038
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222038.
Data sourced from openFDA. This site is unofficial and independent of the FDA.