PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature
FDA 510(k) K974387 · Microwave Medical Systems, Inc.
510(k) numberK974387
Submission
- Device name
- PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature
- Applicant
- Microwave Medical Systems, Inc.
Acton, MA, US - Received
- November 21, 1997
- Decision date
- September 1, 1999
- 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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| 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 |
|---|---|---|
| K932083 | XDCS-100DXT · Traditional | 12/16/1993SE |
| K914867 | QWIK-1(TM) In-Line IV Fluid WarmerLGZ · Traditional | 10/23/1992SE |
| K913110 | PDM-1 Device:Capd Disinfecting Device, ModifiedDRQ · Traditional | 10/10/1991SE |
| K900295 | Peritoneal Dialysis Stystem and AccessoriesKDJ · Traditional | 11/21/1990SE |
Questions and answers
When was PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature cleared by the FDA?
PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature (K974387) received a 510(k) decision of Substantially Equivalent on September 1, 1999, 649 days after the submission was received.
What is the product code of K974387?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.