510(k) K162878
K162878 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Kitazato ET Catheters". The FDA issued a decision of Substantially Equivalent on July 13, 2017. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Kitazato Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2017
- Date Received
- October 14, 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