Peritoneal Dialysis Cycler Set W/Pump
FDA 510(k) K801220 · American Medical Products, Inc.
510(k) numberK801220
Submission
- Device name
- Peritoneal Dialysis Cycler Set W/Pump
- Applicant
- American Medical Products, Inc.
Mchenry, IL, US - Received
- May 22, 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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| 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 |
|---|---|---|
| K922290 | Single-Step Pregnancy, HCG TestJHI · Traditional | 07/09/1992SE |
| K862221 | E-Z CleanGEI · Traditional | 09/12/1986SE |
| K861251 | Amp Closed Urinary Drainage Bag, 1011 & 1011NKNX · Traditional | 04/17/1986SE |
| K830881 | Ampercide Disinfectant Accessory to -FKX · Traditional | 06/02/1983SE |
| K823827 | Amp 80/2 Outflow Monitor ModificationFKX · Traditional | 03/17/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | 10/13/1982SE |
| K822550 | Safe Lock Titanium Adapter SetFKX · Traditional | 10/13/1982SE |
| K822549 | CCPD Cycler Set W/5 Pronged Safe LockFKX · Traditional | 10/13/1982SE |
| K822548 | Safe Lock Catheter S-3FKX · Traditional | 10/13/1982SE |
| K822546 | Safe Lock Sealing CapsFKX · Traditional | 10/13/1982SE |
Questions and answers
When was Peritoneal Dialysis Cycler Set W/Pump cleared by the FDA?
Peritoneal Dialysis Cycler Set W/Pump (K801220) received a 510(k) decision of Substantially Equivalent on August 12, 1980, 82 days after the submission was received.
What is the product code of K801220?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.