SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
FDA 510(k) clearance K964850 · decided 1997-02-25
Clearance details
- K-number
- K964850
- Device name
- SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-12-03
- Decision date
- 1997-02-25
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonp recall (Z-0641-06) | Baxter Healthcare Corp. | 2006-03-24 |
| Baxter Interlink System Minivolume Extension Set, product code 1C8483; An Rx sterile, nonp recall (Z-0642-06) | Baxter Healthcare Corp. | 2006-03-24 |
| Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonp recall (Z-0652-06) | Baxter Healthcare Corp. | 2006-03-24 |
| Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., recall (Z-1100-05) | Baxter Healthcare Corp. | 2005-08-06 |
| Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure Extende recall (Z-1153-03) | Baxter Healthcare Corp. | 2003-08-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |