# K981909: Baxter Hemostasis Valve Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Nov 24, 1998 after 176 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- 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; 3 cite 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) Baxter Healthcare Intro-Flex® Percutaneous Sheath Introducer: named in the summary without a submission number
- (no number) Cook Critical Care Intro Deuce Hemostasis Valve set: named in the summary without a submission number
- (no number) Bard Access Systems Peel-Apart Percutaneous Introducer Kit: named in the summary without a submission number

## Most influential descendants
- K121185: Edwards Percutaneous Sheath Introducer (2012), 1 descendant of its own
- K131627: Catheter Introducer Sheath (2014), 0 descendants of its own
- K133296: XCATH (2014), 0 descendants of its own
- K032962: AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface (2003), 0 descendants of its own

## Recalls of this device
- Jun 15, 2011 · Not classified · Z-2777-2011: Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
- Jun 15, 2011 · Not classified · Z-2776-2011: Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
- May 11, 2009 · Not classified · Z-1913-2009: Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.

## Indications for use
The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.

Source page: https://510kreport.com/device/K981909
Methodology: https://510kreport.com/methodology