# K010874: 6F Mach 1, Model 34356-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 21, 2001 after 90 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
No predicates in its family tree.
160 later devices descend from it; 3 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020028: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX (2002), 132 descendants of its own
- 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

## 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.
- Dec 13, 2006 · Not classified · Z-0383-2007: 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-0382-2007: 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-0388-2007: 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
- May 24, 2004 · Not classified · Z-0432-06: Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F
- May 24, 2004 · Not classified · Z-0433-06: Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F

Source page: https://510kreport.com/device/K010874
Methodology: https://510kreport.com/methodology