MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
FDA 510(k) clearance K925591 · decided 1993-09-16
Clearance details
- K-number
- K925591
- Device name
- MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-05
- Decision date
- 1993-09-16
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- BZR
- Device class
- 2
- Regulation number
- 868.5330
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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 |