# K020028: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Jan 22, 2002 after 18 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010874 (2001). 1 ancestor in all.
132 later devices descend from it; 3 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010874: 6F Mach 1, Model 34356-XXX, Boston Scientific Corp (2001) Summary page 2.

## Most influential descendants
- K061601: Asahi Precious Guide Catheter (2006), 109 descendants of its own
- K093268: Intellivue Patient Monitor (2010), 105 descendants of its own
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (2010), 103 descendants of its own
- K110622: Intellivue Patient Monitor (2011), 90 descendants of its own
- K110474: Philips Intellivue TCG10 (2011), 84 descendants of its own

## Recalls of this device
- Feb 7, 2008 · Not classified · Z-1301-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Feb 7, 2008 · Not classified · Z-1305-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Feb 7, 2008 · Not classified · Z-1304-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Feb 7, 2008 · Not classified · Z-1303-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Feb 7, 2008 · Not classified · Z-1300-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Feb 7, 2008 · Not classified · Z-1302-2008: Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Sep 11, 2007 · Not classified · Z-0104-2008: Missing holes: Catheters are missing the catheter's side holes.
- Dec 13, 2006 · Not classified · Z-0384-2007: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an emboliz
- Dec 13, 2006 · Not classified · Z-0386-2007: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an emboliz
- Dec 13, 2006 · Not classified · Z-0385-2007: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an emboliz
- Dec 13, 2006 · Not classified · Z-0387-2007: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an emboliz

## Indications for use
Mach1 Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K020028
Methodology: https://510kreport.com/methodology