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FDA 510(k)

SPIRALE DRUG DELIVERY SYSTEM

K-Number: K111246 · 2012-08-10

ApplicantArmstrong Medical , Ltd.
Decision Date2012-08-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRALE DRUG DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Armstrong Medical , Ltd.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K111246. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRALE DRUG DELIVERY SYSTEM?

SPIRALE DRUG DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Armstrong Medical , Ltd.. The 510(k) number is K111246.

When did SPIRALE DRUG DELIVERY SYSTEM receive FDA 510(k) clearance?

SPIRALE DRUG DELIVERY SYSTEM received FDA 510(k) clearance on 2012-08-10, under 510(k) number K111246.

Who is the listed applicant for SPIRALE DRUG DELIVERY SYSTEM?

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

What is the FDA product code for SPIRALE DRUG DELIVERY SYSTEM?

The FDA product code for SPIRALE DRUG DELIVERY SYSTEM is CAF.

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Official Source

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