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)

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

K-Number: K964197 · 1997-01-02

ApplicantImpra, Inc.
Decision Date1997-01-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPRA CARBOFLO EPTFE VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1997-01-02 under 510(k) number K964197. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRA CARBOFLO EPTFE VASCULAR GRAFT?

IMPRA CARBOFLO EPTFE VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1997-01-02. The listed applicant is Impra, Inc.. The 510(k) number is K964197.

When did IMPRA CARBOFLO EPTFE VASCULAR GRAFT receive FDA 510(k) clearance?

IMPRA CARBOFLO EPTFE VASCULAR GRAFT received FDA 510(k) clearance on 1997-01-02, under 510(k) number K964197.

Who is the listed applicant for IMPRA CARBOFLO EPTFE VASCULAR GRAFT?

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

What is the FDA product code for IMPRA CARBOFLO EPTFE VASCULAR GRAFT?

The FDA product code for IMPRA CARBOFLO EPTFE VASCULAR GRAFT is DSY.

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 Impra, 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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSK004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSK991027BI-DIRECTIONAL TUNNELERK983769DISTAFLO BYPASS GRAFTK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFT

View all 29 devices →

Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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.

↑