24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524— 510(k) K012143
Substantially EquivalentMedtronic Cardiac Surgical Products
FDA 510(k) clearance K012143 for 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524, Substantially Equivalent on 2001-10-24. Applicant: Medtronic Cardiac Surgical Products.
Clearance details
- Applicant
- Medtronic Cardiac Surgical Products
- Product code
- Code DRA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Grand Rapids, MI, US
Adverse events under product code DRA
product code DRA- Death
- 156
- Injury
- 3,133
- Malfunction
- 6,266
- Total
- 9,555
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.