MERIT HI-FLEX(TM)
FDA 510(k) clearance K883718 · decided 1989-01-30
Clearance details
- K-number
- K883718
- Device name
- MERIT HI-FLEX(TM)
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-31
- Decision date
- 1989-01-30
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- FPK
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Merit Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C recall (Z-2293-2025) | Merit Medical Systems, Inc. | 2025-08-12 |
| Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between recall (Z-1319-2014) | Merit Medical Systems, Inc. | 2014-04-03 |
| Custom Angiographic Kit. recall (Z-0620-03) | Merit Medical Systems, Inc | 2003-03-06 |
| Custom Angiographic Kit recall (Z-0621-03) | Merit Medical Systems, Inc | 2003-03-06 |
| Custom Angiographic Kit recall (Z-0622-03) | Merit Medical Systems, Inc | 2003-03-06 |
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 |