510(k) K161546
K161546 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Corporation for the device "R2P SlenGuide". The FDA issued a decision of Substantially Equivalent on Oct 14, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Ashitaka Factory Of Terumo Corporation has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 14, 2016
- Date Received
- Jun 3, 2016
- 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)