Hemodialysis (SPS), Model 550, Code 5M1309
FDA 510(k) K872364 · Travenol Laboratories, S.A.
510(k) numberK872364
Submission
- Device name
- Hemodialysis (SPS), Model 550, Code 5M1309
- Applicant
- Travenol Laboratories, S.A.
Round Lake, IL, US - Received
- June 18, 1987
- Decision date
- October 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FII – System, Dialysate Delivery, Sealed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FII
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030470 | Nxstage System OneFII · Traditional | Nxstage Medical, Inc. | 07/07/2003SE |
| K881270 | Gambro Multipurpose System MPS-10FII · Traditional | Gambro, Inc. | 08/24/1988SE |
| K862716 | Hemofiltration System 10FII · Traditional | Gambro, Inc. | 09/09/1986SE |
| K822386 | Cotral I W/4.5 L/Hr. Ultrafiltrat. CapaFII · Traditional | Hospal Medical Corp. | 10/06/1982SE |
More from Hospal Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873894 | Continu-Flo Solution W/Check Valve 2 Y-Inject SiteFPA · Traditional | 11/05/1987SE |
| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| 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 |
| K870169 | Capillary Flow DialyzersFJI · Traditional | 04/06/1987SE |
Questions and answers
When was Hemodialysis (SPS), Model 550, Code 5M1309 cleared by the FDA?
Hemodialysis (SPS), Model 550, Code 5M1309 (K872364) received a 510(k) decision of Substantially Equivalent on October 13, 1987, 117 days after the submission was received.
What is the product code of K872364?
The FDA product code is FII – System, Dialysate Delivery, Sealed, a Class II (moderate risk) device regulated under 21 CFR 876.5860.