FDA 510(k)

ASPIRE MAX ASPIRATION CATHETER

K-Number: K113757 · 2012-02-22

ApplicantControl Medical Technology, LLC

Decision Date2012-02-22

Product CodeQEZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASPIRE MAX ASPIRATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Control Medical Technology, LLC. It received FDA 510(k) clearance on 2012-02-22 under 510(k) number K113757. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRE MAX ASPIRATION CATHETER?

ASPIRE MAX ASPIRATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-02-22. The listed applicant is Control Medical Technology, LLC. The 510(k) number is K113757.

When did ASPIRE MAX ASPIRATION CATHETER receive FDA 510(k) clearance?

ASPIRE MAX ASPIRATION CATHETER received FDA 510(k) clearance on 2012-02-22, under 510(k) number K113757.

Who is the listed applicant for ASPIRE MAX ASPIRATION CATHETER?

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

What is the FDA product code for ASPIRE MAX ASPIRATION CATHETER?

The FDA product code for ASPIRE MAX ASPIRATION CATHETER is QEZ.

Related Clinical Trials

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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Other records listing Control Medical Technology, LLC as applicant

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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.