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FDA 510(k)

REPLICATION MEDICAL VESSEL GUARD

K-Number: K082782 · 2009-04-02

ApplicantReplication Medical, Inc.
Decision Date2009-04-02
Product CodeOMR
Advisory CommitteeCV
DecisionUnknown

Device Summary

REPLICATION MEDICAL VESSEL GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Replication Medical, Inc.. It received FDA 510(k) clearance on 2009-04-02 under 510(k) number K082782. The device is classified under product code OMR. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the REPLICATION MEDICAL VESSEL GUARD?

REPLICATION MEDICAL VESSEL GUARD is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Replication Medical, Inc.. The 510(k) number is K082782.

When did REPLICATION MEDICAL VESSEL GUARD receive FDA 510(k) clearance?

REPLICATION MEDICAL VESSEL GUARD received FDA 510(k) clearance on 2009-04-02, under 510(k) number K082782.

Who is the listed applicant for REPLICATION MEDICAL VESSEL GUARD?

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

What is the FDA product code for REPLICATION MEDICAL VESSEL GUARD?

The FDA product code for REPLICATION MEDICAL VESSEL GUARD is OMR.

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Related Devices (Code: OMR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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