Removal System Large Bore 60 cc Syringe
FDA 510(k) K233069 · Inari Medical, Inc.
510(k) numberK233069
Submission
- Device name
- Removal System Large Bore 60 cc Syringe
- Applicant
- Inari Medical, Inc.
Irvine, CA, US - Received
- September 26, 2023
- Decision date
- March 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K163597 | VacLok AT Vacuum SyringePUR · Abbreviated | Merit Medical Systems, Inc. | 07/27/2017SE |
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| K252508 | Intri26 Introducer SheathDYB · Traditional | 12/17/2025SE |
| K253323 | Protrieve SheathQEW · Special | 10/29/2025SE |
| K250421 | InThrill Thrombectomy SystemQEW · Traditional | 05/12/2025SE |
| K250088 | FlowTriever2 CatheterQEW · Traditional | 03/13/2025SE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy SheathQEW · Traditional | 10/15/2024SE |
| K242557 | ClotTriever XL Catheter (41-102)QEW · Special | 09/27/2024SE |
| K234034 | VenaCore Thrombectomy Catheter (46-101)QEW · Traditional | 02/09/2024SE |
| K233815 | ClotTriever SheathQEW · Special | 12/18/2023SE |
| K233646 | Intri24 Introducer Sheath (52-101)DYB · Special | 12/12/2023SE |
Questions and answers
When was Removal System Large Bore 60 cc Syringe cleared by the FDA?
Removal System Large Bore 60 cc Syringe (K233069) received a 510(k) decision of Substantially Equivalent on March 26, 2024, 182 days after the submission was received.
What is the product code of K233069?
The FDA product code is PUR – Vacuum Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.