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FDA 510(k)

SMI CARDIOVASCULAR PACH

K-Number: K112683 · 2011-12-14

ApplicantSolimas Medical, Inc.
Decision Date2011-12-14
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMI CARDIOVASCULAR PACH is the device name listed in this FDA 510(k) record. The listed applicant is Solimas Medical, Inc.. It received FDA 510(k) clearance on 2011-12-14 under 510(k) number K112683. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMI CARDIOVASCULAR PACH?

SMI CARDIOVASCULAR PACH is a medical device that received FDA 510(k) clearance on 2011-12-14. The listed applicant is Solimas Medical, Inc.. The 510(k) number is K112683.

When did SMI CARDIOVASCULAR PACH receive FDA 510(k) clearance?

SMI CARDIOVASCULAR PACH received FDA 510(k) clearance on 2011-12-14, under 510(k) number K112683.

Who is the listed applicant for SMI CARDIOVASCULAR PACH?

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

What is the FDA product code for SMI CARDIOVASCULAR PACH?

The FDA product code for SMI CARDIOVASCULAR PACH is DXZ.

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Related Devices (Code: DXZ)

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

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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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