HORIZON PUMP Y-TYPE BLOOD SET
FDA 510(k) clearance K922637 · decided 1993-06-04
Clearance details
- K-number
- K922637
- Device name
- HORIZON PUMP Y-TYPE BLOOD SET
- Applicant
- Mcgaw, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-04
- Decision date
- 1993-06-04
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0618-2026) | B Braun Medical Inc | 2025-11-26 |
| Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0619-2026) | B Braun Medical Inc | 2025-11-26 |
| Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0620-2026) | B Braun Medical Inc | 2025-11-26 |
| Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock Connector recall (Z-0718-2010) | B. Braun Medical, Inc. | 2010-01-26 |