CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH— 510(k) K854113
Substantially EquivalentAmerican Bentley
FDA 510(k) clearance K854113 for CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH, Substantially Equivalent on 1986-01-08. Applicant: American Bentley.
Clearance details
- Applicant
- American Bentley
- Product code
- Code KRI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.