510(k) K191551
K191551 is an FDA 510(k) premarket notification submitted by Rist Neurovascular, Inc. for the device "RIST Cath Radial Access Long Sheath". The FDA issued a decision of Substantially Equivalent on Dec 23, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Rist Neurovascular, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 2019
- Date Received
- Jun 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)