EZE SIT Valvulotome— 510(k) K190267
Substantially EquivalentLemaitre Vascular
FDA 510(k) clearance K190267 for EZE SIT Valvulotome, Substantially Equivalent on 2019-10-30. Applicant: Lemaitre Vascular. Device class: 2.
Clearance details
- Applicant
- Lemaitre Vascular
- Product code
- Code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
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