510(k) · Cleared

Recalled · 2008

TS Percutaneous Arterial/Venus Catheter Intro Set

K955785510(k) TraditionalCleared Mar 12, 199682-day reviewClass II21 CFR 870.1340Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · DYB Introducer, Catheter

Cleared on Mar 12, 1996 as substantially equivalent to K940092 (Usci, Div. C.R. Bard, Inc., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995. 5 of the 20 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 4 times.

Decided: Mar 12, 1996
Review: 82 days
Class: Class II
Product code: DYB
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K940092 (1995). 18 later devices descend from it, 1 citing it directly. 5 of the 20 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK940092 Usci Input Introducer SetUsci, Div. C.R. Bard, Inc. · 1995
This deviceK955785 TS Percutaneous Arterial/Venus Catheter Intro SetC.R. Bard, Inc. · 1996
Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
Descendant · 4 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
Descendant · 4 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1998high 2 (2009) · low 0 (1999)2026

Class I recalls in this family

K063525 Datascope Fiber Optic Pressure Sensor…4 generations on · 2007
K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump5 generations on · 2011
K181122 CARDIOSAVE Intra-Aortic Balloon Pump6 generations on · 2018
K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump6 generations on · 2015

Most influential descendants

Showing 5 of 18 · See all

K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · 2 generations on15descendants
K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 3 generations on14descendants
K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003 · 4 generations on12descendants
K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940092	Usci Input Introducer Set	Usci, Div. C.R. Bard, Inc.	1995	—
0 (this device)	K955785	TS Percutaneous Arterial/Venus Catheter Intro Set	C.R. Bard, Inc.	1996	—
+1	K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…	Datascope Corp.	1998	—
+2	K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…	Datascope Corp.	2000	—
+3	K013326	Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…	Datascope Corp.	2001	—
+4	K031569	Datascope CA 40 8FR. Iabs, Model 0684-00-04XX	Datascope Corp.	2003	—
+4	K041281	Datascope 7.5FR. Iab Catheter and Accessories	Datascope Corp.	2004	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2007	1	1
2009	2	0
2011	2	1
2012	1	0
2013	1	0
2015	1	1
2017	2	1
2018	1	1

FIG. 1 — Lineage of K955785, 1995–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K940092	Usci Input Introducer Set Summary page 2 …eter Introducer ) 2 Device Classification: Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting Predicate Device: USCI® Input™ Introducer Set (K940092, concurrence received August 10, 1995) Description and Intended Use of Device: Input TS & TL consists of an introducer sheath (…	Usci, Div. C.R. Bard, Inc.	1995	—
†	K781954	Catheter Introducers, Arterise	C.R. Bard, Inc.	1978	—
†	K915553	Usci (R) Hemaflex (TM) Introducer with Coating	C.R. Bard, Inc.	1992	—

Also cleared against K940092: 3 other devices →

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…	Datascope Corp.	1998	17

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 7, 2008	Not classified	Z-0441-2009	Nonconforming Material/Component	Failure to insert the guidewire through the 18 gauge introducer needle
Oct 7, 2008	Not classified	Z-0444-2009	Nonconforming Material/Component	Failure to insert the guidewire through the 18 gauge introducer needle
Oct 7, 2008	Not classified	Z-0442-2009	Nonconforming Material/Component	Failure to insert the guidewire through the 18 gauge introducer needle
Oct 7, 2008	Not classified	Z-0443-2009	Nonconforming Material/Component	Failure to insert the guidewire through the 18 gauge introducer needle

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K980385 (Datascope Corp., 1998) has gone furthest, with 17 descendants of its own.
3 other devices also cite its predicate K940092.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K955785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955785: TS Percutaneous Arterial/Venus Catheter Intro Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955785

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026