510(k) K161967
K161967 is an FDA 510(k) premarket notification submitted by Callisyn Biomedical, Inc. for the device "FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm". The FDA issued a decision of Substantially Equivalent on Jan 27, 2017. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 27, 2017
- Date Received
- Jul 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type
- 510(k)