510(k) K163597
- Device
- VacLok AT Vacuum Syringe
- Applicant
- Merit Medical Systems, Inc.
- 510(k) number
- K163597
- Product code
- PUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-27
- Date received
- 2016-12-21
- Regulation
- 880.5860
- Classification name
- Vacuum Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Angela Brady
- Address
- 1600 W. Merit Pkwy. South Jordan UT US 84095 84095
FDA Registration Numbers#
- 1721676
- 3007279404
- 3015225571
- 3012536737
- 3015309643
- 1721504
- 1724474
- 3006950086
- 3033589330
Source Documents#
Other 510(k) Records For Product Code PUR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | 2024-03-26 |
Legacy Summary#
summary
FDA Review#
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