Freedom Set II with Triflex Valve
FDA 510(k) K870626 · Delmed, Inc.
510(k) numberK870626
Submission
- Device name
- Freedom Set II with Triflex Valve
- Applicant
- Delmed, Inc.
Freehold, NJ, US - Received
- February 13, 1987
- Decision date
- June 3, 1987
- 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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| 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 |
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| 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 |
|---|---|---|
| K895650 | Enteral Pump Set W/Entera-Flo SpikeKNT · Traditional | 10/02/1990SE |
| K895329 | 600ML and 1200ML Enteral Bag Adm. Set for EnteraKNT · Traditional | 10/02/1990SE |
| K895142 | Enteral Pump Set with Enteral SpikeKNT · Traditional | 10/02/1990SE |
| K894506 | Entera-Flo Enteral Feeding PumpFRN · Traditional | 08/06/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | 07/27/1990SE |
| K901477 | Delmed 80/2 Dialysis System W/UltrafiltrationFKX · Traditional | 07/27/1990SE |
| K900106 | Closed Disconnect SystemKDJ · Traditional | 07/16/1990SE |
| K895933 | Enteral Pump Sets for Use with Ross Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895919 | Enteral Bag Admini. Sets for Use W/Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895696 | Enteral Pump Set W/Enteral Spike for Use W/Feed PuKNT · Traditional | 05/02/1990SE |
Questions and answers
When was Freedom Set II with Triflex Valve cleared by the FDA?
Freedom Set II with Triflex Valve (K870626) received a 510(k) decision of Substantially Equivalent on June 3, 1987, 110 days after the submission was received.
What is the product code of K870626?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.