IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
FDA 510(k) clearance K872764 · decided 1987-11-03
Clearance details
- K-number
- K872764
- Device name
- IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
- Applicant
- Y
- Decision
- Substantially Equivalent
- Date received
- 1987-07-13
- Decision date
- 1987-11-03
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx recall (Z-1078-2007) | Cardinal Health 303 Inc DBA Alaris Products | 2007-08-03 |