510(k) K772148
- Device
- CATHETER, FEMORAL VEIN, SF 6
- Applicant
- SORENSEN RESEARCH
- 510(k) number
- K772148
- Product code
- FJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-29
- Date received
- 1977-11-14
- Regulation
- 876.5820
- Classification name
- Intracatheter, Dialysis
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Hematology
- 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 FJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863297 | MODIFICATION'S TO TORAY'S B-2 SERIES | National Medical Care, Medical Products Div., Inc. | 1986-09-25 |
| K772146 | CATHETER, VEIN, FEMORAL, SF 10 | Sorensen Research | 1977-11-29 |
| K770047 | DNC 151 VINCA-FLO | Sorensen Research | 1977-01-14 |
| K760781 | TRIEX-1 HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1976-12-06 |
Legacy Summary#
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FDA Review#
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