# K152090: Reprocessed Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Mar 23, 2016 after 240 days
- Product code: PNE (Reprocessed Catheter Introducer)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964518 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 6.
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 6.

## Recalls of this device
- Sep 17, 2018 · Class II · Z-0090-2019: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
- Jun 2, 2017 · Class I · Z-0213-2018: Inadequate seal due to lack of adhesive glue

## Indications for use
The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K152090
Methodology: https://510kreport.com/methodology