# K043084: Premere Delivery Sheath, Model PDS

- Pathway: 510(k) (Traditional)
- Applicant: Velocimed, Inc.
- Decided: May 2, 2005 after 175 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: 2 generations back to K002054 (2001). 4 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012489: Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10, Appriva Medical, Inc. (2001) Summary page 2.
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 2.
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 2.

## Most influential descendants
- 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
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (2012), 2 descendants of its own

## Indications for use
The Premere TM Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.

Source page: https://510kreport.com/device/K043084
Methodology: https://510kreport.com/methodology