Sta Cath Attachable Infision Catheter, Model STA20
FDA 510(k) K061661 · Advanced Infusion, Inc.
510(k) numberK061661
Submission
- Device name
- Sta Cath Attachable Infision Catheter, Model STA20
- Applicant
- Advanced Infusion, Inc.
San Dimas, CA, US - Received
- June 13, 2006
- Decision date
- October 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Advanced Infusion, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071532 | Alpha Infusion Pump, Model A200, A450MEB · Traditional | 02/19/2008SE |
| K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…MED · Traditional | 07/03/2006SE |
| 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 Sta Cath Attachable Infision Catheter, Model STA20 cleared by the FDA?
Sta Cath Attachable Infision Catheter, Model STA20 (K061661) received a 510(k) decision of Substantially Equivalent on October 18, 2006, 127 days after the submission was received.
What is the product code of K061661?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.