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FDA 510(k)

DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT

K-Number: K082439 · 2009-03-23

ApplicantShandong Weigao Medical Polymer Co., Ltd.
Decision Date2009-03-23
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Medical Polymer Co., Ltd.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K082439. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT?

DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Shandong Weigao Medical Polymer Co., Ltd.. The 510(k) number is K082439.

When did DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT receive FDA 510(k) clearance?

DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT received FDA 510(k) clearance on 2009-03-23, under 510(k) number K082439.

Who is the listed applicant for DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT?

The FDA 510(k) record lists Shandong Weigao Medical Polymer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT?

The FDA product code for DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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