AuST Steerable Sheath

510(k) Number

K260942 ↗

FDA product code

DYB

FDA applicant

CenterPoint Systems, LLC

Device class

Class II

Regulation

21 CFR Part 870.1340

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DYB (Introducer, Catheter).

• Destino Steerable Guiding Sheath DS106750GW by Oscor Inc.
• Super Sheath R/O BT40Z25PPWX35 by TOGO MEDIKIT CO., LTD.
• INTRODUCER SETS, MODEL ADELANTE RADIAL by Oscor Inc.
• The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model by Access Scientific, Inc.
• FIRST PICC INTRODUCER CATHETER by Becton Dickinson Vascular Access, Inc.
• ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX by Daig Corp.
• CATHETER INTRODUCER KIT by Electro-Catheter Corp.
• BIOCARDIA MORPH SHEATH GUIDE by Biocardia, Inc.
• PTFE SUPER SHEATH INTRODUCER by MARTECH MEDICAL PRODUCTS
• SafeSheath CSG 00884450484395 CSGWORLEY109M by Merit Medical Systems, Inc.

• FieldFlex Sheath FXS-MD-002000

  Class II

  FDA 510(k) K261492 Active Cleared 5 Jun 2026 GUDID on market

• FieldFlex Sheath FXS-MD-001599

  Class II

  FDA 510(k) K261492 Active Cleared 5 Jun 2026 GUDID on market

• SSPC NXT Delivery Catheter 9284

  Class II

  FDA 510(k) K243180 Active Cleared 4 Dec 2024 GUDID on market

• SSPC NXT Delivery Catheter 9288

  Class II

  FDA 510(k) K243180 Active Cleared 4 Dec 2024 GUDID on market

See all devices from CenterPoint Systems LLC →