0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING

K955135 · Biocompatibles , Ltd. · DQX · Apr 9, 1996 · Cardiovascular

Device Facts

• Record ID: K955135
• Device Name: 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
• Applicant: Biocompatibles , Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

Device Story

0.014-inch diameter guide wires; 175 cm length; 30 cm radiopaque spring coil distal tip; stainless steel core wire; hydrophilic phosphorylcholine polymer (PCP) coating. Used by physicians in clinical settings to navigate PTA/PTCA balloon catheters through peripheral or coronary vasculature. PCP coating reduces friction during catheter advancement. Device facilitates balloon placement; aids in therapeutic procedures; improves procedural efficiency. Not for cerebral use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

0.014-inch diameter; 175 cm length; stainless steel core; radiopaque spring coil; hydrophilic phosphorylcholine polymer (PCP) coating. Sterilization method not specified.

Indications for Use

Indicated for facilitating placement of PTA and/or PTCA balloon dilatation catheters within peripheral or coronary vasculature. Contraindicated for use in cerebral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque Floppy II® Guide Wire
• Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque Intermediate® Guide Wire

Submission Summary (Full Text)

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APR - 9 1996
K955135

# 510(k) Summary

Submitter's Name:
Biocompatibles Limited
Brunel Science Park
Kingston Lane
Uxbridge
Middlesex UB8 3PQ
England
Tel. [phone]

Contact Person:
Mr. Neil McLaclan
Regulatory Affairs Manager

510(k) Summary Date:
November 9, 1995

Device Names:
0.014" Floppy Guide Wire with
Phosphorylcholine Polymer (PCP) Coating and
0.014" Intermediate Guide Wire with Phosphorylcholine
Polymer (PCP) Coating

Classification Name:
Catheter Guide Wire (21 CFR 870.1330)

Predicate Device:
Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque
Floppy II® Guide Wire and 0.014" Hi-Torque Intermediate®
Guide Wire

Device Description:
The Floppy and Intermediate guide wires have a nominal outside
diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and
have a 30 cm radiopaque spring coil joined distally to a central stainless
steel core wire. The core wire and spring coils are coated with a
hydrophilic phosphorylcholine polymer.

Intended Use:
The Floppy and Intermediate guide wires are intended for use to facilitate
the placement of PTA and/or PTCA balloon dilatation catheters within the
peripheral or coronary vasculature. The guide wires are a 0.014 inch size
and designed for safe use with appropriately sized balloon catheters. The
guide wires are not intended for use in the cerebral vasculature.

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