510(k) K233069
- Device
- Removal System Large Bore 60 cc Syringe
- Applicant
- Inari Medical, Inc.
- 510(k) number
- K233069
- Product code
- PUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-26
- Date received
- 2023-09-26
- Regulation
- 880.5860
- Classification name
- Vacuum Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kaitlyn Weinkauf
- Address
- 6001 Oak Canyon Suite 100 Irvine CA US 92618 92618
FDA Registration Numbers#
- 3006950086
- 1721676
- 3015225571
- 1721504
- 3012536737
- 3033589330
- 1724474
- 3007279404
- 3015309643
Source Documents#
Other 510(k) Records For Product Code PUR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163597 | VacLok AT Vacuum Syringe | Merit Medical Systems, Inc. | 2017-07-27 |