POLYURETHANE INFUSION CATHETER, ALPHA CATH - Polyurethane Infusion Catheter
510(k) K061356
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061356 | Date3 Jul 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MED
- Models / Variants
- Polyurethane Infusion Catheter
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6885
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Polyurethane Infusion Catheter is a medical device designed to deliver local anesthetic to surgical sites or body cavities for post-operative pain relief. It is available in two configurations: Alpha Cath and Multi Drip. The Alpha Cath has an open-end with axial slit ports for blockage bypass, while the Multi Drip has a closed-end with a series of tiny ports for medication distribution.
The device is supplied in specific models, including Model Pac20 and Model Pmd20-6. It is regulated under the FDA with a 510(k) number of K061356. The device is classified as a Sterilant, Medical Device, and is used in a general hospital setting. The manufacturer, Advanced Infusion, Inc., has filed a premarket notification with the FDA for this device.
Other devices from Advanced Infusion, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Polyurethane Infusion Catheter used for?
The Polyurethane Infusion Catheter is used to deliver local anesthetic to surgical sites or body cavities for post-operative pain relief, providing targeted pain management in a general hospital setting.
What configurations are available for the Polyurethane Infusion Catheter?
The Polyurethane Infusion Catheter is available in two configurations: Alpha Cath with an open-end and axial slit ports, and Multi Drip with a closed-end and tiny ports for medication distribution.
How is the Polyurethane Infusion Catheter supplied?
The device is supplied in specific models, including Model Pac20 and Model Pmd20-6, and is classified as a Sterilant, Medical Device.
What is the regulatory status of the Polyurethane Infusion Catheter?
The device is regulated under the FDA with a 510(k) number of K061356, indicating that it has been found substantially equivalent to a predicate device.