New Travenol Roller Clamp-Solution Admin. Set
FDA 510(k) K854517 · Travenol Laboratories, S.A.
510(k) numberK854517
Submission
- Device name
- New Travenol Roller Clamp-Solution Admin. Set
- Applicant
- Travenol Laboratories, S.A.
Deerfield, IL, US - Received
- November 12, 1985
- Decision date
- December 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKK – Clamp, Line
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K854512 | Tubing Clamp CAT#1000-AFKK · Traditional | Rao Medical Devices, Inc. | 12/02/1985SE |
| K844121 | Clamp, Tubing, LineFKK · Traditional | Dyn-A-Med Products | 12/17/1984SE |
| K831689 | Empty Dialysate ContainerFKK · Traditional | Delmed, Inc. | 08/11/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | Pollak (Intl.), Ltd. | 10/31/1980SE |
More from Pollak (Intl.), Ltd.
| 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 |
| 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 New Travenol Roller Clamp-Solution Admin. Set cleared by the FDA?
New Travenol Roller Clamp-Solution Admin. Set (K854517) received a 510(k) decision of Substantially Equivalent on December 2, 1985, 20 days after the submission was received.
What is the product code of K854517?
The FDA product code is FKK – Clamp, Line, a Class I (low risk) device regulated under 21 CFR 876.4730.