The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Vaclok At Vacuum Syringe.
| Device ID | K163597 |
| 510k Number | K163597 |
| Device Name: | VacLok AT Vacuum Syringe |
| Classification | Vacuum Syringe |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Angela Brady |
| Correspondent | Angela Brady Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | PUR |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2017-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450271791 | K163597 | 000 |
| 10884450271787 | K163597 | 000 |