VacLok AT Vacuum Syringe
FDA 510(k) clearance K163597 · decided 2017-07-27
Clearance details
- K-number
- K163597
- Device name
- VacLok AT Vacuum Syringe
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-21
- Decision date
- 2017-07-27
- Days to decision
- 218 days
- Clearance type
- Abbreviated
- Product code
- PUR
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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| Removal System Large Bore 60 cc Syringe (K233069) | Inari Medical, Inc. | 2024-03-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |