MIDMARK MIDLINE CATHETER

K951620 · Menlo Care, Inc. · FOZ · Apr 4, 1996 · General Hospital

Device Facts

• Record ID: K951620
• Device Name: MIDMARK MIDLINE CATHETER
• Applicant: Menlo Care, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Peripherally inserted catheter for venous access or intravenous therapy.

Device Story

Peripherally inserted catheter for venous access/intravenous therapy; inserted via introducer; optimal tip location below shoulder at axilla level. Available in single/dual lumen configurations; provided as sterile individual units or with insertion trays. Used by clinicians for vascular access; facilitates delivery of intravenous fluids/medications.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single and dual lumen configurations; materials identical to Centermark (K920828). Sterilization: electron radiation for catheter units, ethylene oxide for insertion trays. Non-pyrogenicity verified via LAL procedure.

Indications for Use

Indicated for patients requiring venous access or intravenous therapy via peripherally inserted catheter.

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

• V-Cath® ML
• L-CATH® Mid Line (K924968)

Reference Devices

• Centermark (K920828)

Submission Summary (Full Text)

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K951620

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION FOR MIDMARK™ MIDLINE CATHETER

1. **Classification Name**: Catheter, Intravascular 80FOZ
**Common Name**: Peripherally Inserted Catheter
**Proprietary Name**: MIDMARK™ Midline Catheter

2. **Establishment Registration Number**: 2938241

3. **Establishment Name/Address**: Menlo Care, Inc.
1350 Willow Rd., Suite 101
Menlo Park, CA 94025

4. **Classification**: Class II

5. **Substantially Equivalent Devices**: V-Cath® ML, L-CATH® Mid Line (K924968)

6. **Description and Device Function**: Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations; as sterile individual units or in trays along with the components used for insertion.

7. **Component Specifications**: All Midmark components and materials are identical to that of Centermark (K920828).

8. **Performance Standards**: No performance standards have been established by the FDA.

9. **Packaging and Sterilization**: These devices will be packaged in peelable polymer pouches and sterilized by exposure to high energy electron radiation. Insertion trays will be sterilized by exposure to ethylene oxide.

Non-pyrogenicity will be established for each production lot by the LAL procedure.

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