FIRST MIDCATH CATHETER WITH DUAL LUMENS

K964049 · Becton Dickinson Vascular Access, Inc. · FOZ · Jan 6, 1997 · General Hospital

Device Facts

• Record ID: K964049
• Device Name: FIRST MIDCATH CATHETER WITH DUAL LUMENS
• Applicant: Becton Dickinson Vascular Access, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.

Device Story

FIRST MIDCATH™ is a single-use, dual-lumen, long-term intravascular catheter; available in various French sizes and lengths. Device provides vascular access for blood sampling and intravenous administration of fluids/medications. Inserted into large veins (basilic or cephalic) via a splittable introducer catheter. Used by clinicians in hospital or clinical settings. Device facilitates patient therapy by providing reliable venous access.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate.

Technological Characteristics

Dual-lumen, long-term intravascular catheter; single-use; various French sizes/lengths. Materials and design concept identical to predicate FIRST PICC™.

Indications for Use

Indicated for patients requiring vascular access for blood sampling or intravenous administration of fluids, blood products, or medications via large veins such as the basilic or cephalic veins.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• FIRST PICC™ brand catheters

Submission Summary (Full Text)

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K96 4049
Jan. 6, 1997

# 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 8, 1996.

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

Name: Midline Catheter with Dual Lumens
Brand: FIRST MIDCATH™
Common Name: Midline Catheter with Dual Lumens
Classification Name: Long Term Intravascular Catheter (80 LJS)

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

Predicate Device: The Becton Dickinson Vascular Access FIRST PICC™ brand catheters.

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

The subject catheter is a long term, single use, dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.

E. Statement of intended use of the device.

The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.

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 FIRST PICC™ brand catheter in that it is shorter however, the materials used, the design concept, the manner in which the catheter is placed, and designation as a long term catheter are the same.

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