# K172315: Straub Endovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Straub Medical AG
- Decided: Apr 12, 2018 after 254 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K871011 (1987). 65 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133023: Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6, Medrad, Inc. (2014) Summary page 4.
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371, Asahi Intecc Co., Ltd. (2007) Summary page 4.

## Most influential descendants
- K211738: Rotarex Atherectomy System (2021), 1 descendant of its own
- K242757: Rotarex Atherectomy System (2025), 0 descendants of its own

## Recalls of this device
- Feb 5, 2025 · Class I · Z-1244-2025: Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix,

## Indications for use
When operated with a Rotarex S single use catheter, the Straub Endovascular System is intended for use as an atherectomy device and to break up and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, pulmonary, iliac or renal vasculature.

Source page: https://510kreport.com/device/K172315
Methodology: https://510kreport.com/methodology