CE-MDR and FDA Cleared 8G Kyphoplasty Balloon Catheter 10mm KB0210

Name: "CE-MDR and FDA Cleared 8G Kyphoplasty Balloon Catheter 10mm KB0210"
Rating: 5 (294 reviews)

SKU: 7785000220

الطراز: KB0210

CHANGMEI Kyphoplasty

دخول المتجر

تفاصيل البضائع

CE-MDR and FDA Cleared 8G Kyphoplasty Balloon Catheter 10mm KB0210

Model: KB0210 | Size: 8G | Distance of Two Radiopaque Markers: 10 mm

The Changmei Kyphoplasty Balloon Catheter KB0210 is a single-use, inflatable bone tamp for percutaneous balloon kyphoplasty (PKP). It is CE-MDR marked and ISO 13485 certified, with U.S. FDA 510(k) clearance (K223709, Product Code HRX, Class II, 21 CFR 888.1100, cleared August 16, 2023). This 8G catheter features a 10 mm distance between two radiopaque markers, a channel inner diameter of ≥3.65 mm, an overall length of 315 mm, a maximum inflation volume of 4 cc, and a constrained burst pressure of ≥400 PSI. It is designed to create a cavity for PMMA bone cement injection, restore vertebral height, and reduce pain.

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High Burst Pressure

≥400 PSI constrained burst pressure ensures reliable performance during inflation.

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Regulatory Clearance

CE-MDR, ISO 13485, and FDA 510(k) cleared (K223709).

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Compact 8G Design

8G size with 10 mm marker distance for precise placement.

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4 cc Max Volume

Allows controlled cavity creation in vertebral body.

Technical Specifications

Parameter	Specification
Model	KB0210
Size/Type	8G
Distance of Two Radiopaque Markers	10 mm
Channel Inner Diameter	≥3.65 mm
Overall Length	315 mm
Maximum Volume	4 cc
Constrained Burst Pressure	≥400 PSI
Sterilization	EO sterilized, single use

Models and Options

KB0210 (this model): 8G, 10 mm marker distance, 4 cc max volume
KB0115: 8G, 15 mm marker distance (mentioned in catalog)
KB0120: 8G, 20 mm marker distance (mentioned in catalog)

Materials and Structure

Balloon film: Medical-grade thermoplastic polyurethane (TPU)
Shaft: PU with stainless-steel (06Cr19Ni10) stylet reinforcement
Radiopaque marker: Tantalum (Ta) marker band
Handle: Polycarbonate
STERILIZATION: EO sterilized, 3-year shelf life

Applications

Indicated for minimally invasive treatment of painful vertebral compression fractures (VCFs) caused by osteoporosis, low-energy trauma, or neoplasia. Also for symptomatic vertebral hemangiomas. Used in orthopedic surgery, spine surgery, pain management, interventional pain clinics.

Customization

Changmei offers OEM/ODM support. Customized orders with negotiable minimum quantity based on specific requirements.

Frequently Asked Questions

What is the burst pressure of the KB0210 balloon?

The constrained burst pressure is ≥400 PSI, ensuring safety during inflation.

How is the catheter sterilized?

Each unit is ethylene-oxide sterilized and validated for a 3-year shelf life.

What is the maximum inflation volume?

The maximum inflation volume is 4 cc, suitable for controlled cavity creation.

Is this product FDA cleared?

Yes, it has FDA 510(k) clearance (K223709) and is CE-MDR marked.

What is the overall length?

The overall length is 315 mm, designed for transpedicular access.

Can it be used with other Changmei kits?

It is designed to pair with Changmei KT-00-01 8G tool kit and BI-20A-10 balloon inflator.

What is the MOQ?

MOQ for standard in-stock products is 10 sets. OEM/ODM minimums are negotiable.

Inquiry Information

Contact: Mark
Email: cyz@czmed.com
Tel/WhatsApp: +86 138-1368-7682
Address: No.27 Xinke West Road, Luoyang Town, Wujin District, Changzhou City, Jiangsu, China.

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Product Images

Kyphoplasty balloon catheter KB0210 8G 10mm - product view