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FDA 510(k)

FLEXIBLE OCCLUSION SYSTEM

K-Number: K002915 · 2001-01-08

ApplicantApplied Medical
Decision Date2001-01-08
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE OCCLUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2001-01-08 under 510(k) number K002915. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE OCCLUSION SYSTEM?

FLEXIBLE OCCLUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Applied Medical. The 510(k) number is K002915.

When did FLEXIBLE OCCLUSION SYSTEM receive FDA 510(k) clearance?

FLEXIBLE OCCLUSION SYSTEM received FDA 510(k) clearance on 2001-01-08, under 510(k) number K002915.

Who is the listed applicant for FLEXIBLE OCCLUSION SYSTEM?

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

What is the FDA product code for FLEXIBLE OCCLUSION SYSTEM?

The FDA product code for FLEXIBLE OCCLUSION SYSTEM is DXC.

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Related Devices (Code: DXC)

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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.

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