# K101599: RVT Cto Device

- Pathway: 510(k) (Traditional)
- Applicant: Revascular Therapeutics, Inc.
- Decided: Jan 18, 2011 after 225 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 9 generations back to K890505 (1989). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072776: The Crosser System, Flowcardia, Inc. (2007) Summary page 2.
- K091119: Modification to the Crosser System, Flowcardia, Inc. (2009) Summary page 2.
- K051670: RF Tunneler Wire, Baylis Medical Co., Inc. (2006) Summary page 2.

## Most influential descendants
- K140288: Truepath Cto Device (2014), 0 descendants of its own

## Indications for use
The RVT CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.

Source page: https://510kreport.com/device/K101599
Methodology: https://510kreport.com/methodology