# K955785: TS Percutaneous Arterial/Venus Catheter Intro Set

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 12, 1996 after 82 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940092 (1995). 1 ancestor in all.
18 later devices descend from it; 1 cites it directly.
5 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940092: Usci Input Introducer Set, Usci, Div. C.R. Bard, Inc. (1995) Summary page 2.

## Most influential descendants
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (2000), 15 descendants of its own
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), 14 descendants of its own
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX (2003), 12 descendants of its own
- K041281: Datascope 7.5FR. Iab Catheter and Accessories (2004), 11 descendants of its own

## Recalls of this device
- Oct 7, 2008 · Not classified · Z-0441-2009: Failure to insert the guidewire through the 18 gauge introducer needle
- Oct 7, 2008 · Not classified · Z-0444-2009: Failure to insert the guidewire through the 18 gauge introducer needle
- Oct 7, 2008 · Not classified · Z-0442-2009: Failure to insert the guidewire through the 18 gauge introducer needle
- Oct 7, 2008 · Not classified · Z-0443-2009: Failure to insert the guidewire through the 18 gauge introducer needle

## Indications for use
Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.

Source page: https://510kreport.com/device/K955785
Methodology: https://510kreport.com/methodology