FDA 510(k)

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS

K-Number: K092896 · 2010-10-29

Decision Date2010-10-29

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K092896. 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 REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS?

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K092896.

When did REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS receive FDA 510(k) clearance?

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS received FDA 510(k) clearance on 2010-10-29, under 510(k) number K092896.

Who is the listed applicant for REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS?

The FDA 510(k) record lists Nemoto Kyorindo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS?

The FDA product code for REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS is DXT.

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Official Source

View on FDA Database →

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