# 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

- Pathway: 510(k) (Traditional)
- Applicant: Appriva Medical, Inc.
- Decided: Feb 16, 2001 after 225 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
No predicates in its family tree.
11 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012489: Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10 (2001), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K002054
Methodology: https://510kreport.com/methodology