The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Squirt Fluid Delivery System.
Device ID | K162777 |
510k Number | K162777 |
Device Name: | Squirt Fluid Delivery System |
Classification | Catheter, Continuous Flush |
Applicant | Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
Contact | Angela Brady |
Correspondent | Angela Brady Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-03 |
Decision Date | 2016-10-31 |
Summary: | summary |