SSC8 Sorenson Subclavian Catheter
FDA 510(k) K801478 · Sorensen Research
510(k) numberK801478
Submission
- Device name
- SSC8 Sorenson Subclavian Catheter
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- August 27, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIQ – Cannula, A-V Shunt
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K892887 | ST Series Saf-T-Shunts Arteriovenous CannulaFIQ · Traditional | Akcess Medical Products, Inc. | 05/15/1989SE |
| K892666 | Saf-T-Shunt, S-300 SeriesFIQ · Traditional | Akcess Medical Products, Inc. | 05/04/1989SE |
| K892663 | S-100 Allen-Brown ShuntFIQ · Traditional | Akcess Medical Products, Inc. | 05/04/1989SE |
| K844692 | Pediatric Sized Hemocath CatheterFIQ · Traditional | Quinton, Inc. | 01/18/1985SE |
| K841791 | Plume Fistula NeedleFIQ · Traditional | Hospal Medical Corp. | 07/09/1984SE |
| K840322 | Hemofiltration Catheter HF-100FIQ · Traditional | Vas-Cath of Canada , Ltd. | 04/24/1984SE |
| K840415 | HemocathFIQ · Traditional | Quinton, Inc. | 04/20/1984SE |
| K834358 | Parallel Dual Lumen Subclavian CannulaFIQ · Traditional | Vas-Cath of Canada , Ltd. | 04/02/1984SE |
| K840436 | Hemasite/Renaloy -Vascular Access ShuntFIQ · Traditional | Renal Systems, Inc. | 02/21/1984SE |
| K833622 | Renalloy Hemasite Vascular Access ShuntFIQ · Traditional | Renal Systems, Inc. | 11/29/1983SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | 01/25/1984SE |
| K833673 | Accurate Measurement Device Ez-AmdGCX · Traditional | 12/29/1983SE |
| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K820706 | Waterless Seal & Vacuum RegulatorKDP · Traditional | 04/09/1982SE |
Questions and answers
When was SSC8 Sorenson Subclavian Catheter cleared by the FDA?
SSC8 Sorenson Subclavian Catheter (K801478) received a 510(k) decision of Substantially Equivalent on August 27, 1980, 64 days after the submission was received.
What is the product code of K801478?
The FDA product code is FIQ – Cannula, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.