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FDA 510(k)

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS

K-Number: K091593 · 2009-06-22

ApplicantPossis Medical, Inc.
Decision Date2009-06-22
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS is the device name listed in this FDA 510(k) record. The listed applicant is Possis Medical, Inc.. It received FDA 510(k) clearance on 2009-06-22 under 510(k) number K091593. 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 ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS?

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS is a medical device that received FDA 510(k) clearance on 2009-06-22. The listed applicant is Possis Medical, Inc.. The 510(k) number is K091593.

When did ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS receive FDA 510(k) clearance?

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS received FDA 510(k) clearance on 2009-06-22, under 510(k) number K091593.

Who is the listed applicant for ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS?

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

What is the FDA product code for ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS?

The FDA product code for ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS is QEZ.

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Other records listing Possis Medical, Inc. as applicant

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.

K090253ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001K082382ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039K081989MODIFICATION TO FETCH ASPIRATION CATHETERK081454GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICEK080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608K073441ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

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Related Devices (Code: QEZ)

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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