# K083793: Steerable Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Evalve, Inc.
- Decided: Apr 27, 2009 after 126 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002054 (2001). 9 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043084: Premere Delivery Sheath, Model PDS, Velocimed, Inc. (2005) Summary page 1.
- K034025: NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSC, Nmt Medical, Inc. (2004) Summary page 1.
- K002054: X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1, Appriva Medical, Inc. (2001) Summary page 1.
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 1.
- K052644: Swartz Braided Transseptal Guiding Introducer, St Jude Medical (2005) Summary page 1.

## Most influential descendants
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST (2009), 7 descendants of its own
- K093866: Evalve Steerable Guide Catheter (2010), 6 descendants of its own
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST (2010), 5 descendants of its own
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (2012), 2 descendants of its own
- K131332: Cardiosolutions Percu-Pro Steerable Introducer (2013), 1 descendant of its own

## Indications for use
The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K083793
Methodology: https://510kreport.com/methodology