FOUNTAIN Infusion Catheter and Occluding Guide Wire
FDA 510(k) clearance K992231 · decided 1999-07-23
Clearance details
- K-number
- K992231
- Device name
- FOUNTAIN Infusion Catheter and Occluding Guide Wire
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-02
- Decision date
- 1999-07-23
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY recall (Z-0629-2024) | Merit Medical Systems, Inc. | 2024-01-02 |
| Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South J recall (Z-2107-2008) | Merit Medical Systems, Inc. | 2008-09-11 |
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 |