Type: | Suture Closure |
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Application: | Vascular |
Material: | Plastic |
Feature: | Disposable |
Certification: | CE, ISO13485 |
Group: | Adult |
Samples: |
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Customization: |
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Clothoid Vascular Closure System is a suture mediated device to close femoral artery puncture site with a single monofilament polypropylene following dignostic or interventional catheterization procedures.
The Clothoid Vascular Closure System is designed for patients who have undergone dignostic or interventional catheterization procedures using 5F to 21F sheaths. The pre-knot polypropylene suture is delivered percutaneously to close the common femoral artery access site. At least two devices are needed to close arteriotomy sites using an 8-21F procedural sheath.
1. Professional global regulatory consulting team
Our team founders have more than 20 years of experience in medical device quality management and product registration at home and abroad who previously served as Quality Engineering Supervisor at Zimmer Biomet, Management Representative and QA Manager at Medtronic Comfort, later Quality Regulation Director at Scion US and Scion China. Completed many F*D*A 510K applications and CE product registration in EU, and organized several F*D*A audits in the United States and large-scale international audits by ANVISA in Brazil.
2. Professional research & development, quality control and sales team
We have good contact with advanced global medical company's experts. Also attend their summit to keep knowledge of latest medical industry technology or products. Most of our employees are highly educated.
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