TRICOS T RESORBABLE BONE SUBSTITUTE
FDA 510(k) clearance K073571 · decided 2008-04-08
Clearance details
- K-number
- K073571
- Device name
- TRICOS T RESORBABLE BONE SUBSTITUTE
- Applicant
- Baxter Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-12-20
- Decision date
- 2008-04-08
- Days to decision
- 110 days
- Clearance type
- Abbreviated
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mcgaw Park, 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 |