Removal System Large Bore 60 cc Syringe
FDA 510(k) clearance K233069 · decided 2024-03-26
Clearance details
- K-number
- K233069
- Device name
- Removal System Large Bore 60 cc Syringe
- Applicant
- Inari Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-26
- Decision date
- 2024-03-26
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- PUR
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VacLok AT Vacuum Syringe (K163597) | Merit Medical Systems, Inc. | 2017-07-27 |
Recalls involving this device
No recalls on record reference this clearance.