FIRST PICC INTRODUCER CATHETER

K954906 · Becton Dickinson Vascular Access, Inc. · DYB · Apr 8, 1996 · Cardiovascular

Device Facts

• Record ID: K954906
• Device Name: FIRST PICC INTRODUCER CATHETER
• Applicant: Becton Dickinson Vascular Access, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.

Device Story

FIRST PICC™ introducer catheter; short-term, single-use device. Inserted into vascular system over needle; designed to split and peel away after use. Facilitates placement of guidewires, central venous catheters, PICCs, and probes. Used by clinicians in clinical settings. Benefits patient by enabling secure, temporary vascular access for secondary device insertion.

Clinical Evidence

Bench testing only.

Technological Characteristics

Short-term, single-use intravascular catheter. Splittable design. Various gauges and lengths. Sterile.

Indications for Use

Indicated for patients requiring vascular access for the placement of guidewires, central venous catheters, peripherally inserted central venous catheters, and probes.

Regulatory Classification

Identification

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

Predicate Devices

• Becton Dickinson Vascular Access INSYTE® brand introducer catheter
• Becton Dickinson Vascular Access SPLIT SECOND® brand introducer catheter
• Teleflex, Inc. Percutaneous Introducer Set

Submission Summary (Full Text)

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K954906

# SUMMARY OF SAFETY AND EFFICACY

A. The submitter’s name, address, telephone number, contact person, and date of preparation.

Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070.
Contact: C. J. Welle. Telephone: [phone]. Prepared: October 24, 1995.

B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.

Name: Introducer Catheter
Brand: FIRST PICC™
Common Name: Introducer Catheter
Classification Name: Intravascular Catheter (80 FOZ)

C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:

Predicate Device: The Becton Dickinson Vascular Access INSYTE® brand and SPLIT SECOND® brand introducer catheters and the Teleflex, Inc. Percutaneous Introducer Set.

D. A description of the device that is the subject of the Premarket Notification submission.

The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.

E. Statement of intended use of the device.

The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.

F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.

The proposed catheter differs from the INSYTE® brand introducer catheter in that it is splittable; however, the intended use is the same. It is similar to the SPLIT SECOND® brand introducer catheter and the Teleflex, Inc. Percutaneous Introducer Set in that both are splittable and both are introducer catheters.

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