U9000 Plus Ultrafilter
FDA 510(k) clearance K211035 · decided 2021-10-19
Clearance details
- K-number
- K211035
- Device name
- U9000 Plus Ultrafilter
- Applicant
- Baxter Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-04-07
- Decision date
- 2021-10-19
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Preveleak Surgical Sealant (P100030/S021) | Baxter Healthcare Corporation | 2025-07-10 |
| PerClot® Polysaccharide Hemostatic System (P210036/S005) | Baxter Healthcare Corporation | 2025-04-25 |
| Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020) | Baxter Healthcare Corporation | 2025-04-11 |
| PerClot Polysaccharide Hemostatic System (P210036/S002) | Baxter Healthcare Corporation | 2024-12-20 |
| Seprafilm Adhesion Barrier (P950034/S059) | Baxter Healthcare Corporation | 2024-12-19 |
| PerClot Polysaccharide Hemostatic System (P210036/S004) | Baxter Healthcare Corporation | 2024-07-18 |
| Seprafilm Adhesion Barrier (P950034/S058) | Baxter Healthcare Corporation | 2024-07-03 |
| Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019) | Baxter Healthcare Corporation | 2024-06-06 |