# K221414: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Silk Road Medical, Inc.
- Decided: Sep 2, 2022 after 109 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 6 generations back to K001134 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter, Cordis Europa, N.V. (2007) Summary page 4.

## Indications for use
The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

Source page: https://510kreport.com/device/K221414
Methodology: https://510kreport.com/methodology