Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled— 510(k) K200205
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K200205 for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled, Substantially Equivalent on 2020-05-13. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.