# K133177: Modified HD Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Feb 25, 2014 after 131 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003880 (2001). 8 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090335: HD Guide Catheter, Concentric Medical, Inc. (2009) Summary page 1.
- K110483: Modified HD Guide Catheter, Concentric Medical, Inc. (2011) Summary page 2.
- K112404: Concentric Balloon Guide Catheter, Concentric Medical, Inc. (2012) Summary page 2.

## Most influential descendants
- K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (2015), 26 descendants of its own
- K180715: React 68 Catheter (2018), 19 descendants of its own
- K183463: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm (2019), 14 descendants of its own
- K190833: AXS Vecta Aspiration Catheter (2019), 6 descendants of its own
- K191237: CERENOVUS Large Bore Catheter (2019), 5 descendants of its own

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1908-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc
- Apr 3, 2024 · Class II · Z-1740-2024: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-spe
- Aug 19, 2015 · Class II · Z-0116-2016: One Distal Access Catheter intended for distribution in Korea, was found at a US location.

## Indications for use
The Concentric HID Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K133177
Methodology: https://510kreport.com/methodology