PERCUTANEOUS INTRODUCER, MODEL 10383-XXX

K000824 · Medamicus, Inc. · DYB · Apr 13, 2000 · Cardiovascular

Device Facts

• Record ID: K000824
• Device Name: PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
• Applicant: Medamicus, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 13, 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.