510(k) K771705
- Device
- RS-7800 MINIPUMP
- Applicant
- RENAL SYSTEMS, INC.
- 510(k) number
- K771705
- Product code
- FIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-04
- Date received
- 1977-09-09
- Regulation
- 876.5820
- Classification name
- Pump, Blood, Extra-luminal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961137 | ATI PLASMA PUMP (PP-04) | Apheresis Technologies, Inc. | 1996-06-14 |
| K831953 | INFUSION PUMP | Cryosan, Inc. | 1983-07-19 |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Parker Hannifin Corp. | 1983-04-12 |
| K821139 | SPS-SINGLE PATIENT SYSTEM | Extracorporeal Medical Specialities, Inc. | 1982-05-10 |
| K780410 | BLOOD PUMP-MODE S10K | 3M Health Care, Sarns | 1978-05-03 |
| K761050 | HEPARIN PUMP | Dws, Inc. | 1976-12-30 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases