B. BRAUN GUIDEWIRES

K961107 · B.Braun Medical, Inc. · DQX · Oct 1, 1996 · Cardiovascular

Device Facts

• Record ID: K961107
• Device Name: B. BRAUN GUIDEWIRES
• Applicant: B.Braun Medical, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral, reproductive, or neurological procedures.

Device Story

Steerable, shapeable guidewire; used to direct catheters through blood vessels during PTCA/PTA procedures. Available in various diameters, stiffnesses, and lengths. Extendible versions feature proximal attachment for extension wire; allows intravascular device exchange while maintaining distal position. Extension wire is removable; restores original length/functionality. Used by clinicians in interventional settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Steerable, shapeable guidewire; available in multiple diameters, lengths, and stiffnesses. Features proximal attachment mechanism for extension wire compatibility. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing PTCA and PTA procedures requiring catheter navigation through blood vessels. Contraindicated for cerebral, reproductive, or neurological procedures.

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

• ACS Guidewires (K852123, K852354, K854830, K861574, K861765, K862360, K864585, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066, K950156)
• Target Guidewires (K884198, K922912, K914032)
• USCI Guidewires (K924009, K933466)

Submission Summary (Full Text)

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K961107

OCT 1 1996

## II. SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address: B. Braun Medical Inc., Cardiovascular Division
824 Twelfth Avenue
Bethlehem, Pa 18018

Contact: Mark Alsberge, Regulatory Affairs Manager

Date Prepared: June 21, 1996

Common or Usual Name: B. Braun Guidewires

Device Classification Name: Wire, Guide, Catheter

Substantial Equivalence: ACS Guidewires-- K852123, K852354, K854830, K861574, K861765, K862360, K864585, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156
Target Guidewires--K884198, K922912 / or K914032
USCI Guidewires--K924009 / or K933466

Guidewire Device Description: The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety of diameters, stiffnesses, and lengths. Certain sizes are extendible to exchange lengths.

Extendible guidewires have an attachment at the proximal end of the guidewire which is adapted to receive a Braun Guidewire extension wire. Extending the guidewire enables exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.

Extension Wire Device Description: The Braun Guidewire extension wire is available in sizes compatible with Braun Guidewire extendible guidewires. The distal end of the extension is adapted to engage the proximal end of the guidewire enabling exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.

Statement of Intended Use:

The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral, reproductive, or neurological procedures.