# K971165: Introducer Sheath and Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 23, 1997 after 114 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- 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. The FDA summary names its predicate without a number.
- (no number) Cook’s Peel-Away® Introducers: named in the summary without a submission number
- (no number) B. Braun's Tearaway Introducer: named in the summary without a submission number

## Most influential descendants
- K981611: Snap-N-Peel Introducers (1998), 6 descendants of its own
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), 5 descendants of its own
- K020563: Medamicus Axia RSN (2002), 3 descendants of its own
- K120160: Rocamed Rocaus Platinum (2012), 2 descendants of its own
- K022689: Modification to Medamicus Axia RSN (2002), 2 descendants of its own

## Indications for use
The Introducer Sheath and Dilator is used for percutaneous introduction of catheters and guide wires.

Source page: https://510kreport.com/device/K971165
Methodology: https://510kreport.com/methodology