Chinese OEM Percutaneous Coronary Intervention Therapy Micro Guide Wire

Customization:	Available
Coating:	Teflon & Hydrophilic Coating
Tolerance:	+/-0.005mm

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Basic Specifications

Model NO.

FB10397

OEM

Accept OEM

Approval Scope

Class III

Load at The Tip

1.0g

Radiopaque Length

3cm

Friction Coefficient

Less Than 0.1n

Length

180-300cm

Specification Model

0.010''/0.014''

HS Code

9018909000

Production Capacity

1,000,000 PCS/Year

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Dual-Core Coronary Guidewire Technical Dossier

1. Dual-Core Structural Design

Component	Material & Function
Inner Core Wire	Superelastic Nitinol (SE508), Ø0.005"-0.008", provides shape recovery and kink resistance
Outer Support Core	High-yield stainless steel (316LVM), Ø0.010"-0.012", enhances pushability and torque transmission
Taper Transition	Laser gradient welding (Tensile strength ≥80gf at transition zone)

Composite Coating System:

Proximal Segment: PTFE coating (2-5μm) for reduced catheter friction
Distal Segment: Hydrophilic-hydrophobic hybrid coating (e.g., PVP+silicone) for optimized trackability

2. Performance Advantages

Parameter	Dual-Core	Single-Core
Push Efficiency	+40% improvement (≥92% transmission)	65-75% typical
Kink Resistance	>500 cycles (1.5mm bend radius)	200-300 cycles
Tip Responsiveness	<5° torque delay (1:1.05 ratio)	10-15° delay

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Clinical Applications & Manufacturing

Clinical Synergy

Complex Lesions:

CTOs: Outer core provides penetration force (up to 3g tip load).
Calcified Vessels: Dual-core synergy minimizes whipping effect.

Compatibility:

Retrograde PCI: Maintains stability through collateral channels.
OCT/IVUS: Radiopaque markers (Ta+Au plating) for clear imaging.

Critical Manufacturing Requirements

Concentricity Control: ≤0.001" deviation via laser monitoring.
Heat Treatment: Stage-aged (Nitinol: 400°C/1h; SS: 300°C/2h).
Coating Curing: UV+vacuum annealing (adhesion ≥1.5N/mm).

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Manufacturing Excellence

Established in 2019, we are a comprehensive entity integrating medical device R&D, production, and service. The facility has passed ISO13485:2016 certification, covering over 5,000 square meters with a professional workforce of over 100 people.

Grinding Workshop

Parylene Coating Workshop

Laser Cutting Workshop

Marking Workshop

Inspection Workshop

10,000 Level Purification Workshop

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Corporate Culture

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Frequently Asked Questions

1. Q: What range of medical components do you provide?

A: Our business covers interventional implantable metal consumables, coated mandrels for catheters, neurointerventional core wires, PTFE/Parylene coated guidewires, Hypotubes, platinum developing rings, and specialized welding and cutting services.

2. Q: What quality certifications do you hold?

A: We are certified under the ISO 13485:2016 quality management system for medical devices.

3. Q: What are the standard payment terms?

A: Our standard term is full payment in advance.

4. Q: Do you require specific documents for custom quotations?

A: Yes, for customized products, we require either technical drawings or prototypes to ensure accurate production.

5. Q: Can we protect our intellectual property?

A: Absolutely. We are happy to sign a Non-Disclosure Agreement (NDA) to ensure your designs remain confidential.

6. Q: What is your production capacity?

A: We have a large-scale capacity of up to 1,000,000 pieces per year across our specialized workshops.