Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) +4 more— 510(k) K243373
Substantially EquivalentVitrolife Sweden AB
FDA 510(k) clearance K243373 for Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) +4 more, Substantially Equivalent on 2025-07-23. Applicant: Vitrolife Sweden AB. Device class: 2.
Clearance details
- Device name as filed
- Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
- Applicant
- Vitrolife Sweden AB
- Product code
- Code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Västra Frölunda, SE
Recent devices under product code MQF
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- K231730 — FemaSeed Intratubal Insemination
- K220010 — Daylily Single Use Sterile Embryo Transfer Catheter
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
More clearances from Vitrolife Sweden AB
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