COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
FDA 510(k) clearance K002211 · decided 2000-07-28
Clearance details
- K-number
- K002211
- Device name
- COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 2000-07-21
- Decision date
- 2000-07-28
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- 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 |
|---|---|---|
| Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Bax recall (Z-0344-05) | Baxter Healthcare Corp. | 2004-12-22 |
| Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; recall (Z-0345-05) | Baxter Healthcare Corp. | 2004-12-22 |
| Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Baxter Healthc recall (Z-0881-04) | Baxter Healthcare Corp. | 2004-07-20 |
| Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healt recall (Z-0882-04) | Baxter Healthcare Corp. | 2004-07-20 |
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 |