# K061356: Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Infusion, Inc.
- Decided: Jul 3, 2006 after 49 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896422 (1990). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021964: Alpha Infusion Pump and Catheters, Advanced Infusion, Inc. (2002) Summary page 1.
- K042246: Multi-Drip Infusion Catheter, Advanced Infusion, Inc. (2004) Summary page 1.
- K003915: Accufuser; Accufuser Plus, Help Technologies (2001) Summary page 1.
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (2000) Summary page 1.

## Indications for use
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.

Source page: https://510kreport.com/device/K061356
Methodology: https://510kreport.com/methodology