Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)— 510(k) K191015
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K191015 for Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip), Substantially Equivalent on 2019-05-17. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- 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
- Special
- Location
- Bloomington, IN, US
Recent devices under product code MQF
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- K220010 — Daylily Single Use Sterile Embryo Transfer Catheter
More clearances from Cook Incorporated
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