510(k) K191606
K191606 is an FDA 510(k) premarket notification submitted by Renovorx, Inc. for the device "RenovoCath". The FDA issued a decision of Substantially Equivalent on August 7, 2019. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Renovorx, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2019
- Date Received
- June 17, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular Occluding, Temporary
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type