# K053491: Penumbra Balloon Guide Catheter, Model 7.5F

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Apr 27, 2006 after 133 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010954 (2001). 2 ancestors in all.
106 later devices descend from it; 1 cites it directly.
4 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021899: Concentric Balloon Guide Catheter, Model 90072, Concentric Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K070970: Neuron Support Catheter System, Model 5F/6F (2007), 105 descendants of its own
- K082290: Neuron Delivery Catheter 070 (2008), 88 descendants of its own
- K083125: Neuron Select Catheter Size 070 (2008), 86 descendants of its own
- K111380: Neuron Max System (2011), 61 descendants of its own
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (2018), 27 descendants of its own

## Indications for use
The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.

Source page: https://510kreport.com/device/K053491
Methodology: https://510kreport.com/methodology