QC Cap
FDA 510(k) K945567 · Medionics International, Inc.
510(k) numberK945567
Submission
- Device name
- QC Cap
- Applicant
- Medionics International, Inc.
Markham, Ontario, CA - Received
- September 27, 1994
- Decision date
- February 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/03/2025SE |
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| 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 |
|---|---|---|
| K130441 | Faller StyletFJS · Traditional | 04/19/2013SE |
| K993149 | Peritoneal Dialysis Catheters and AdaptersFJS · Traditional | 04/28/2000SE |
| K994218 | Easy Care and Tubing SetsFKX · Special | 02/10/2000SE |
| K910173 | Selectra and Tubing SetsFKX · Traditional | 01/13/1992SE |
| K883393 | Capd Disposable Y System - Dy SetKDJ · Traditional | 11/03/1988SE |
| K842305 | C.A.P.D. Automatic Heater PDH 200FKX · Traditional | 06/25/1984SE |
| K832141 | Microstar VC1 Volumetric CyclerFKX · Traditional | 10/14/1983SE |
| K831766 | Microstar VciFKX · Traditional | 10/14/1983SE |
| K821328 | C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional | 07/28/1982SE |
Questions and answers
When was QC Cap cleared by the FDA?
QC Cap (K945567) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 133 days after the submission was received.
What is the product code of K945567?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.