MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB— 510(k) K904556
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K904556 for MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB, Substantially Equivalent on 1991-12-18. Applicant: Boston Scientific Corp. Device class: 1.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code IOL
- Device class
- Class 1
- Regulation
- 21 CFR 890.5380
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.