Who is the manufacturer of FIRST MIDCATH CATHETER KIT?

Becton Dickinson Vascular Access, Inc. filed the 510(k) submission for FIRST MIDCATH CATHETER KIT (K964048).

What is the FDA product code for FIRST MIDCATH CATHETER KIT?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for FIRST MIDCATH CATHETER KIT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FIRST MIDCATH CATHETER KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FIRST MIDCATH CATHETER KIT

K964048 · Becton Dickinson Vascular Access, Inc. · FOZ · Jan 6, 1997 · General Hospital

Device Facts

Record ID	K964048
Device Name	FIRST MIDCATH CATHETER KIT
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 kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above.

Device Story

FIRST MIDLINE™ catheter kit; single or dual lumen, long-term intravascular catheter; provides venous access for blood sampling or fluid/drug administration. Used in clinical settings for insertion into large veins (basilic/cephalic). Kit includes catheter plus site preparation, placement, securement, and dressing components. Physician or qualified clinician performs insertion. Device facilitates therapy delivery and diagnostic sampling; benefits patient by providing reliable venous access.

Clinical Evidence

Bench testing only.

Technological Characteristics

Long-term, single-use, single or dual lumen intravascular catheter. Materials, design, and placement methodology consistent with predicate. Sterile kit configuration.

Indications for Use

Indicated for patients requiring intravenous access for blood sampling or administration of drug solutions, blood products, or other fluids 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 kit

Related Devices

K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS · Becton Dickinson Vascular Access, Inc. · Jan 6, 1997
K972264 — FIRST MIDCATH CATHETER · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 15, 1997
K163452 — PICC Maximal Barrier Nursing Kit · Navilyst Medical, Inc. · Feb 3, 2017
K011860 — KEYST0NE MEDICAL PICC CATHETER · Keystone Medical · Jun 27, 2001
K972262 — FIRST PICC CATHETER · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 15, 1997

Submission Summary (Full Text)

{0} K964048 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: 801-565-2535. 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 Kit Brand: FIRST MIDLINE™ Common Name: Midline Catheter Kit Classification Name: None. The catheter component is classified as a 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 kit. D. A description of the device that is the subject of the Premarket Notification submission. The subject kit contains a long term, single use, single or 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 also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site. E. Statement of intended use of the device. The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above. 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 kit differs from the FIRST PICC™ brand kit in that the FIRST MIDLINE™ catheter is shorter than the FIRST PICC™ catheter; 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. Other componentry varies to meet customer needs. 39 002