Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter— 510(k) K153006
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K153006 for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter, Substantially Equivalent on 2016-06-23. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- 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
- Plymouth, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.