Flo-Gard 4000 Volumetric Infusion Controller
FDA 510(k) K854863 · Travenol Laboratories, S.A.
510(k) numberK854863
Submission
- Device name
- Flo-Gard 4000 Volumetric Infusion Controller
- Applicant
- Travenol Laboratories, S.A.
Deerfield, IL, US - Received
- December 5, 1985
- Decision date
- February 12, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
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More from The Master Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
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| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
Questions and answers
When was Flo-Gard 4000 Volumetric Infusion Controller cleared by the FDA?
Flo-Gard 4000 Volumetric Infusion Controller (K854863) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 69 days after the submission was received.
What is the product code of K854863?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.