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Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, And Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6

by Advanced Infusion, Inc.

510(k) K061356

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061356 Date3 Jul 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MED
Models / Variants
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.