# K133023: Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Aug 27, 2014 after 335 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K871011 (1987). 44 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130637: Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 System, Medrad, Inc. (2013) Summary page 7.

## Most influential descendants
- K172315: Straub Endovascular System (2018), 2 descendants of its own
- K211738: Rotarex Atherectomy System (2021), 1 descendant of its own
- K242757: Rotarex Atherectomy System (2025), 0 descendants of its own

## Recalls of this device
- Apr 5, 2017 · Class II · Z-1922-2017: Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREA

## Indications for use
The JETSTREAM System is intended for use in atherectomy of the the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K133023
Methodology: https://510kreport.com/methodology