SOLUTION ADMIN. SET 2C9096 W/10 PVC
FDA 510(k) clearance K832284 · decided 1983-12-29
Clearance details
- K-number
- K832284
- Device name
- SOLUTION ADMIN. SET 2C9096 W/10 PVC
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-13
- Decision date
- 1983-12-29
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, e recall (Z-0193-05) | Baxter Healthcare Corp. | 2004-11-16 |
| Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing Seg recall (Z-1157-03) | Baxter Healthcare Corp. | 2003-08-21 |