SARNS 8000 MODULAR PERFUSION SYSTEM— 510(k) K915183
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K915183 for SARNS 8000 MODULAR PERFUSION SYSTEM, Substantially Equivalent on 1992-07-08. Applicant: 3M Health Care, Sarns.
Clearance details
- Applicant
- 3M Health Care, Sarns
- Product code
- Code DTQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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.