Bio-Medicus Life Support Catheter and Introducer— 510(k) K201057
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K201057 for Bio-Medicus Life Support Catheter and Introducer, Substantially Equivalent on 2022-01-14. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code QHW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
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