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)

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

K-Number: K081454 · 2008-06-13

ApplicantPossis Medical, Inc.
Decision Date2008-06-13
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE 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 2008-06-13 under 510(k) number K081454. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE?

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 2008-06-13. The listed applicant is Possis Medical, Inc.. The 510(k) number is K081454.

When did GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE receive FDA 510(k) clearance?

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE received FDA 510(k) clearance on 2008-06-13, under 510(k) number K081454.

Who is the listed applicant for GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE?

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 GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE?

The FDA product code for GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE is MJN.

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 CATHETERK080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608K073441ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

View all 33 devices →

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

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.

↑