# K012489: Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10

- Pathway: 510(k) (Special)
- Applicant: Appriva Medical, Inc.
- Decided: Aug 30, 2001 after 27 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002054 (2001). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K043084: Premere Delivery Sheath, Model PDS (2005), 9 descendants of its own
- K083793: Steerable Guide Catheter (2009), 8 descendants of its own
- 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

## Indications for use
The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

Source page: https://510kreport.com/device/K012489
Methodology: https://510kreport.com/methodology