510(k) K162064
K162064 is an FDA 510(k) premarket notification submitted by Crossbay Medical, Inc. for the device "CrossBay IVF Embryo Transfer Catheter Set". The FDA issued a decision of Substantially Equivalent on January 5, 2017. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Crossbay Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2017
- Date Received
- July 26, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type