MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
FDA 510(k) clearance K802166 · decided 1980-11-12
Clearance details
- K-number
- K802166
- Device name
- MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1980-09-08
- Decision date
- 1980-11-12
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- FLN
- Device class
- 2
- Regulation number
- 880.2420
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| DRIP ALERT (K030136) | Drip Alert, Inc. | 2003-04-07 |
| STRYKER L3 HYDROLERT (K022248) | Stryker Endoscopy | 2002-08-06 |
| MT ALERT INFUSION MONITOR (K013121) | Sierra Biosearch, Inc. | 2001-10-15 |
| FLUID CENTURION (4-100-00) (K973025) | Northgate Technologies, Inc. | 1997-11-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (K972084) | Alexander Mfg. Co. | 1997-07-03 |
| AC-901 I.V. INFUSION DROP COUNTER (K923561) | Lamtic, Inc. | 1993-05-26 |
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 |