510(k) K211910
K211910 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "Z-6 Atrioseptostomy Catheter". The FDA issued a decision of Substantially Equivalent on Jul 19, 2021. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. NuMED, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 2021
- Date Received
- Jun 21, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type