Clirans TE15 Hollow Fiber Dialyzer
FDA 510(k) K801193 · Terumo America, Inc.
510(k) numberK801193
Submission
- Device name
- Clirans TE15 Hollow Fiber Dialyzer
- Applicant
- Terumo America, Inc.
Mchenry, IL, US - Received
- May 19, 1980
- Decision date
- August 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | Baxter Healthcare | 03/12/2024SE |
| K214016 | 15L Cycler Drainage BagKDJ · Traditional | Baxter Healthcare Corporation | 03/18/2022SE |
| K192705 | MiniCap Extended Life PD Transfer SetsKDJ · Special | Baxter Healthcare | 10/25/2019SE |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/21/2018SE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/14/2018SE |
| K173363 | Cycler Drain Bag SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/24/2018SE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional | Puracath Medical, Inc. | 01/20/2016SE |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
More from Baxter Healthcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K811523 | Plasma FlexKSR · Traditional | 09/09/1981SE |
| K802970 | Terumo Hollow Fiber OxygenatorDTZ · Traditional | 01/22/1981SE |
| K802441 | Clirans TH10 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K802122 | Clirans TH13 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K801194 | Clirans TE07 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K801192 | Clirans TE10 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K791411 | Coaxial Dual Flow CatheterKOC · Traditional | 11/13/1979SE |
| K791173 | Surflo Injection PlugFPA · Traditional | 07/30/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | 05/24/1979SE |
| K772362 | Avf Set for Single Needle HemodialysisFIE · Traditional | 03/17/1978SE |
Questions and answers
When was Clirans TE15 Hollow Fiber Dialyzer cleared by the FDA?
Clirans TE15 Hollow Fiber Dialyzer (K801193) received a 510(k) decision of Substantially Equivalent on August 12, 1980, 85 days after the submission was received.
What is the product code of K801193?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.