Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Introducer, Catheter

FDA product code DYB · 659 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1340
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-16 – 2026-07-29

DYB 1985-06-21

PERCUTANEOUS ANGIOGRAPHIC NEEDLES

Applicant Mallinckrodt Critical Care

K number K845037

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DYB 1985-06-21

CARDIOVASCULAR CUSTOM SURGICAL KIT

Applicant Xanmed Corp.

K number K844593

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DYB 1985-05-16

TELEFLEX MEDICAL INTRODUCER CATHETER

Applicant Teleflexmedical, Inc.

K number K851141

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DYB 1985-05-16

DESERET INTRODUCER SET

Applicant Parke-Davis Co.

K number K844840

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DYB 1985-04-19

HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER

Applicant Hdc Corp.

K number K851078

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DYB 1985-04-10

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID

Applicant Universal Medical Instrument Corp.

K number K850820

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DYB 1985-03-06

PEEL-AWAY INTRODUCER SET

Applicant Quinton, Inc.

K number K844693

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DYB 1984-12-27

MEADOX SURGIMED A/S CATHETER SHEATH SYS

Applicant Meadox Surgimed, Inc.

K number K843798

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DYB 1984-11-13

CANNULA INTRODUCER

Applicant Cardiovascular Research, Inc.

K number K843118

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DYB 1984-10-23

SUBCLAVIAN LEAD INTRODUCER SYS

Applicant Xanmed Corp.

K number K843642

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DYB 1984-10-23

CATHETER INTRODUCER SYSTEM

Applicant Xanmed Corp.

K number K843641

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DYB 1984-10-18

SINGLE WALL INTRODUCER NEEDLE

Applicant Ocean Medical Products, Ltd.

K number K843719

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DYB 1984-10-18

FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN

Applicant Cardio-Vascular Innovations, Inc.

K number K843500

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DYB 1984-08-03

MEDTRONIC 6210 PERMANENT LEAD INTRODUC

Applicant Medtronic Vascular

K number K842780

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DYB 1984-08-01

PCI W/CATH-SEAL SIDE FLOW FITTING

Applicant Universal Medical Instrument Corp.

K number K842259

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DYB 1984-07-13

PERCUTANEOUS CATHETER INTRODUCER SET

Applicant Aries Medical, Inc.

K number K842004

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DYB 1984-05-23

EMERGENCY INFUSION DEVICE

Applicant Arrow Intl., Inc.

K number K840455

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DYB 1984-04-17

ANGIOGRAPHY NEEDLE W/WO CONNECTION

Applicant Dlp, Inc.

K number K840923

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DYB 1984-03-19

PERCUTANEOUS SHEATH INTRODUCER TRAY

Applicant Packaging Technologies, Inc.

K number K834074

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DYB 1983-10-20

LEAD INTRODUCER SETS-EB-S8 & EB-S12

Applicant Oscor, Inc.

K number K831751

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DYB 1983-04-28

CORONARY GUIDING CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K number K830829

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DYB 1983-04-28

FRENCH PERCUTANEOUS SHEATH INTRODUCER

Applicant Norton Performance Plastics Corp.

K number K830813

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DYB 1983-01-18

MODEL SP5800 #8 FRENCH INTRO. KIT

Applicant Gould, Inc.

K number K823262

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DYB 1982-11-01

ACCESS PERCUTANEOUS INTRODUCER SET

Applicant Access Devices, Inc.

K number K822834

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DYB 1982-09-28

PERCUTANEOUS CATHETER INTRODUCER SET

Applicant Vertex Medical Corp.

K number K822593

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DYB 1982-08-19

CATH-SEAL

Applicant Universal Medical Instrument Corp.

K number K822247

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DYB 1982-07-14

ARGYLE INTRAMEDICUT CATHETER KIT

Applicant Sherwood Medical Co.

K number K821324

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DYB 1982-07-08

INTRODUCER SET

Applicant Advanced Cardiovascular Systems, Inc.

K number K821188

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DYB 1982-04-14

PERCOR PERCUTANEOUS INTRODUCER

Applicant Datascope Corp.

K number K820834

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DYB 1982-04-01

NEONATAL INTRODUCER KIT

Applicant Norton Performance Plastics Corp.

K number K820710

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DYB 1982-03-18

NORTON JUGULAR KITS

Applicant Norton Performance Plastics Corp.

K number K820581

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DYB 1981-11-27

DESILET

Applicant Exco, Inc.

K number K813143

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DYB 1981-11-16

PERCUTANEOUS INTRODUCER: SELDINGER STYLE

Applicant Dip, Inc.

K number K813019

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DYB 1981-11-16

PERCUTANEOUS INTRODUCER COURNAND STYLE

Applicant Dip, Inc.

K number K812973

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DYB 1981-11-16

INTRODUCER, PERCUTANEOUS SELDINGER

Applicant Triad Medical Division

K number K812964

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DYB 1981-10-13

IMPLANTAID LEAD INTRODUCER #319-10 & 12

Applicant Intermedics, Inc.

K number K812502

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DYB 1981-09-21

INTK-08 8 FRENCH INTRODUCER KIT W/SIDE

Applicant Sorensen Research

K number K812325

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DYB 1981-08-18

INTRODUCER, PERCUTANEOUS

Applicant Willson

K number K812143

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DYB 1980-05-28

PERMANENT LEAD INTRADUCER

Applicant Daig Corp.

K number K800356

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DYB 1980-04-24

PERCUTANEOUS CATHETER INTRODUCER ADAPTER

Applicant Norton Performance Plastics Corp.

K number K800621

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DYB 1980-04-24

VENOUS M/A INTERNAL JUGULAR KIT

Applicant Norton Performance Plastics Corp.

K number K800620

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DYB 1980-04-24

THERMODILUTION CATHETER INTRO. KIT

Applicant Norton Performance Plastics Corp.

K number K800619

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DYB 1980-04-02

PERCUTANEOUS CATHETER INTRODUCER

Applicant Alva Medical, Inc.

K number K800580

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DYB 1979-11-13

PERCUTANEOUS SHEATH INTRO. KIT OR TRAY

Applicant Stanco Medical, Inc.

K number K792172

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DYB 1979-11-13

COMPLETE TRAY CENTRAL VENOUS PRESSURE

Applicant Stanco Medical, Inc.

K number K792171

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DYB 1979-11-13

PERCUTANEOUS SHEATH (MULTI-CATH)SIDE

Applicant Stanco Medical, Inc.

K number K792170

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DYB 1979-11-13

TEMPORARY TRANSVENOUS PACMKER. ELECTRODE

Applicant Stanco Medical, Inc.

K number K792131

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DYB 1979-11-13

TRANSVENOUS BALLOON CATH. INTRO. KIT

Applicant Stanco Medical, Inc.

K number K792130

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DYB 1979-11-13

USCI MULLINS TRANSSEPTAL CATHETER INTRO.

Applicant C.R. Bard, Inc.

K number K791963

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DYB 1979-07-17

PERMANENT LEAD INTRADUCER

Applicant Daig Corp.

K number K791129

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DYB 1979-02-01

INTRODUCERS

Applicant Clincal Instruments Corp.

K number K790034

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DYB 1978-11-29

CATHETER INTRODUCERS, ARTERISE

Applicant C.R. Bard, Inc.

K number K781954

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DYB 1978-04-21

PERCUTANEOUS SHEATH INTRODUCER KIT

Applicant Arrow Intl., Inc.

K number K780532

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DYB 1977-11-02

888 ARTERIAL/VENOUS CATHETER INTRODUCER

Applicant Usci, Div. C.R. Bard, Inc.

K number K771982

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DYB 1977-07-13

INTRODUCER, CAT. #INT-05FR.

Applicant Sorensen Research

K number K771042

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DYB 1977-07-13

INTRODUCER, CAT. #INT-06FR.

Applicant Sorensen Research

K number K771041

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DYB 1977-06-29

INTRODUCER, CAT. #INT-07FR.

Applicant Sorensen Research

K number K771040

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DYB 1977-04-26

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH

Applicant Usci, Div. C.R. Bard, Inc.

K number K770561

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DYB 1977-03-16

CATHETER INTRODUCER KIT

Applicant Electro-Catheter Corp.

K number K770427

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