FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX

K001367 · St. Jude Medical, Inc. · DYB · May 31, 2000 · Cardiovascular

Device Facts

• Record ID: K001367
• Device Name: FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
• Applicant: St. Jude Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 31, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.