# K132030: Micra Introducer Sheath with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Sep 27, 2013 after 88 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Medtronic Sentrant Introducer Sheath: named in the summary without a submission number

## Most influential descendants
- K140793: Nanostim Introducer Kit (2014), 3 descendants of its own
- K160716: The Nanostim Introducer Kit (2016), 2 descendants of its own
- K161102: Nanostim Introducer Kit (2016), 1 descendant of its own
- K211989: Aveir Introducer (2021), 0 descendants of its own

## Indications for use
The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions.

Source page: https://510kreport.com/device/K132030
Methodology: https://510kreport.com/methodology