Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6
FDA 510(k) K061356 · Advanced Infusion, Inc.
510(k) numberK061356
Submission
- Device name
- Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6
- Applicant
- Advanced Infusion, Inc.
Tempe, AZ, US - Received
- May 15, 2006
- Decision date
- July 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid…MED · Special | STERIS Corporation | 10/03/2023SE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED · Special | STERIS Corporation | 03/28/2023SE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 09/28/2022SE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Traditional | STERIS Corporation | 09/07/2021SE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 05/12/2021SE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 12/10/2019SE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED · Special | STERIS Corporation | 09/05/2019SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
More from STERIS Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K071532 | Alpha Infusion Pump, Model A200, A450MEB · Traditional | 02/19/2008SE |
| K061661 | Sta Cath Attachable Infision Catheter, Model STA20MEB · Traditional | 10/18/2006SE |
| K042246 | Multi-Drip Infusion CatheterMEB · Traditional | 08/31/2004SE |
| K021964 | Alpha Infusion Pump and CathetersMEB · Traditional | 08/12/2002SE |
| K992551 | Alpha Infusion PumpMEB · Traditional | 10/27/1999SE |
Questions and answers
When was Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6 cleared by the FDA?
Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6 (K061356) received a 510(k) decision of Substantially Equivalent on July 3, 2006, 49 days after the submission was received.
What is the product code of K061356?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.