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FDA 510(k)

INTRALUMINAL ARTERY STRIPPER

K-Number: K913803 · 1992-04-24

ApplicantOmni-Tract Surgical, Div. Minn. Scientific, Inc.
Decision Date1992-04-24
Product CodeDWX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRALUMINAL ARTERY STRIPPER is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. It received FDA 510(k) clearance on 1992-04-24 under 510(k) number K913803. The device is classified under product code DWX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRALUMINAL ARTERY STRIPPER?

INTRALUMINAL ARTERY STRIPPER is a medical device that received FDA 510(k) clearance on 1992-04-24. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. The 510(k) number is K913803.

When did INTRALUMINAL ARTERY STRIPPER receive FDA 510(k) clearance?

INTRALUMINAL ARTERY STRIPPER received FDA 510(k) clearance on 1992-04-24, under 510(k) number K913803.

Who is the listed applicant for INTRALUMINAL ARTERY STRIPPER?

The FDA 510(k) record lists Omni-Tract Surgical, Div. Minn. Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRALUMINAL ARTERY STRIPPER?

The FDA product code for INTRALUMINAL ARTERY STRIPPER is DWX.

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 Omni-Tract Surgical, Div. Minn. Scientific, 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.

K001339MRI FASTSYSTEM RETRACTOR SYSTEMK992583MASS (MICRO-ACCESS SPINE SYSTEM)K950214ABDOMINAL WALL RETRACTOR

Related Devices (Code: DWX)

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.

K121415MOLLRING MULTITASCLeMaitre Vascular, Inc.K032105ENDOHELIX ENDARTERECTOMY DEVICEEndarx, Inc.K020925CARBODISSECTING ENDOSCOPEEndo Surgical Devices, Inc.K003719VASCULAR ARCHITECTS PERISCOPE DEVICEVascular Architects, Inc.K950813MOLLRING CUTTERCardio Vascular Concepts, Inc.K933498EXTERNAL VEIN STRIPPERApplied Medical Resources

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.

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