MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
FDA 510(k) clearance K884913 · decided 1989-04-18
Clearance details
- K-number
- K884913
- Device name
- MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-28
- Decision date
- 1989-04-18
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliSystem Inflation Device, REF: IN1525/D recall (Z-0067-2025) | Merit Medical Systems, Inc. | 2024-10-11 |
| Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATAL recall (Z-0512-2010) | Merit Medical Systems, Inc. | 2009-12-14 |
| Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation recall (Z-0513-2010) | Merit Medical Systems, Inc. | 2009-12-14 |
| Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filt recall (Z-0515-2010) | Merit Medical Systems, Inc. | 2009-12-14 |
| Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220 recall (Z-0516-2010) | Merit Medical Systems, Inc. | 2009-12-14 |
| IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in recall (Z-0138-04) | Merit Medical Systems, Inc | 2003-11-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S005) | Merit Medical Systems, Inc. | 2026-06-11 |
| 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 |