# K934901: Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Jan 21, 1994 after 99 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
4 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K122084: Introducer Set, Model Adelante-S Series (2012), 2 descendants of its own
- K143255: Prelude SNAP Splittable Sheath Introducer (2015), 1 descendant of its own
- K201116: Abiomed 23 Fr Sheath (2020), 0 descendants of its own
- K192769: Impella CP Introducer (2019), 0 descendants of its own
- K152381: Prelude SNAP Splittable Hydrophilic Sheath Introducer (2015), 0 descendants of its own

## Recalls of this device
- Dec 16, 2010 · Not classified · Z-1226-2011: Compromised sterility/weak or open seals.
- Dec 16, 2010 · Not classified · Z-1225-2011: Compromised sterility/weak or open seals.
- Dec 16, 2010 · Not classified · Z-1228-2011: Compromised sterility/weak or open seals.
- Oct 1, 2008 · Not classified · Z-0280-2009: Failure to insert the guidewire through the introducer needle.
- Sep 12, 2008 · Not classified · Z-0131-2009: Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
- Nov 7, 2005 · Not classified · Z-0297-06: mislabeled as 9.5F actually contains 10.5F
- Oct 14, 2004 · Not classified · Z-0056-05: Sheaths may fracture if exposed to excess fluorescent light

Source page: https://510kreport.com/device/K934901
Methodology: https://510kreport.com/methodology