# K014075: BMC Coaxial Injectable Catheter, Model Cic 38/145 and Cic 35/145

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Mar 7, 2002 after 86 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 28, 2015 · Class II · Z-0356-2016: Microcatheter may have circumferential defects (cracks) along its shaft.
- Mar 30, 2015 · Class II · Z-1442-2015: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

## Indications for use
The BMC Coaxial Injectable Catheter is intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

Source page: https://510kreport.com/device/K014075
Methodology: https://510kreport.com/methodology