The following data is part of a premarket notification filed by Callisyn Biomedical, Inc. with the FDA for Fluiditube 2.7f Infusion Micro Catheter, 110 Cm And 130 Cm.
| Device ID | K161967 |
| 510k Number | K161967 |
| Device Name: | FluidiTube 2.7F Infusion Micro Catheter, 110 Cm And 130 Cm |
| Classification | Catheter, Continuous Flush |
| Applicant | Callisyn Biomedical, Inc. 260 Candlestick Road North Andover, MA 01845 |
| Contact | Shallwei Sun |
| Correspondent | Gordon Macfarlane ICON 62 Forest Street, Suite 300 Marlborough, MA 01752 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2017-01-27 |
| Summary: | summary |