# K992309: Introducer Sheath, Vessel Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 7, 1999 after 90 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.
13 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)
- None. The FDA summary names its predicate without a number.
- (no number) Percutaneous Introducer Set: named in the summary without a submission number
- (no number) Long Length Percutaneous Introducer Set: named in the summary without a submission number
- (no number) EPT Constellation Outer Guiding Catheters: named in the summary without a submission number
- (no number) Fast-Cath™ Intracardiac Introducer: named in the summary without a submission number
- (no number) Cook Toughy-Borst Introducer set: named in the summary without a submission number

## Most influential descendants
- K013866: Convoy Advanced Delivery Sheath Kit (2001), 12 descendants of its own
- K072719: Convoy Advanced Delivery Sheath (2008), 11 descendants of its own
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own

## Indications for use
The Boston Scientific/EP Technologies sheaths and accessories are desighed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncturc has been obtained by another sheath.

Source page: https://510kreport.com/device/K992309
Methodology: https://510kreport.com/methodology