SPS 550-IPS (INTEGRATED PATIENT STATION)
FDA 510(k) clearance K901038 · decided 1990-04-19
Clearance details
- K-number
- K901038
- Device name
- SPS 550-IPS (INTEGRATED PATIENT STATION)
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-03-06
- Decision date
- 1990-04-19
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- FIL
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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| REPGREEN ULTRAFILTRATION MONITOR (K790824) | Cyberex Corp. | 1979-06-27 |
| ULTRAFILTRATION SCALE (K781633) | Extracorporeal Medical Specialities, Inc. | 1978-12-07 |
| ULTRAFILTRATION MONITOR 5M9034 (K771875) | Travenol Laboratories, S.A. | 1977-11-30 |
| AK-10 (K771227) | Gambro, Inc. | 1977-08-02 |
| NEGATIVE PRESSURE ADAPTER 5M1350 (K770137) | Travenol Laboratories, S.A. | 1977-02-01 |
Recalls involving this device
No recalls on record reference this clearance.
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 |