Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS

K-Number: K072769 · 2007-11-14

ApplicantPossis Medical, Inc.
Decision Date2007-11-14
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) 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 2007-11-14 under 510(k) number K072769. 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 ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS?

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS is a medical device that received FDA 510(k) clearance on 2007-11-14. The listed applicant is Possis Medical, Inc.. The 510(k) number is K072769.

When did ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS receive FDA 510(k) clearance?

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS received FDA 510(k) clearance on 2007-11-14, under 510(k) number K072769.

Who is the listed applicant for ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) 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 ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS?

The FDA product code for ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K091593ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETSK090253ANGIOJET 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 106608

View all 33 devices →

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.

K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo NeuroK261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis Medical

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.

↑