VacLok AT Vacuum Syringe
FDA 510(k) K163597 · Merit Medical Systems, Inc.
510(k) numberK163597
Submission
- Device name
- VacLok AT Vacuum Syringe
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- December 21, 2016
- Decision date
- July 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PUR – Vacuum Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
Other 510(k)s with product code PUR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233069 | Removal System Large Bore 60 cc SyringePUR · Traditional | Inari Medical, Inc. | 03/26/2024SE |
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Questions and answers
When was VacLok AT Vacuum Syringe cleared by the FDA?
VacLok AT Vacuum Syringe (K163597) received a 510(k) decision of Substantially Equivalent on July 27, 2017, 218 days after the submission was received.
What is the product code of K163597?
The FDA product code is PUR – Vacuum Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.