510(k) K160598
K160598 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "REBOA Balloon Catheter". The FDA issued a decision of Substantially Equivalent on June 20, 2016. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. NuMED, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2016
- Date Received
- March 2, 2016
- 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