510(k) K190813
K190813 is an FDA 510(k) premarket notification submitted by Crossbay Medical for the device "CrossBay Cervical Dilator Catheter System". The FDA issued a decision of Substantially Equivalent on August 23, 2019. The device falls under product code PON (Catheter, Balloon, Dilation Of Cervical Canal), a Class II device regulated under 21 CFR 884.4260. Crossbay Medical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2019
- Date Received
- March 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Balloon, Dilation Of Cervical Canal
- Device Class
- Class II
- Regulation Number
- 884.4260
- Review Panel
- OB
- Submission Type
Mechanical dilation and softening of the cervix.