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)

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

K-Number: K954848 · 1996-02-01

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1996-02-01
Product CodeMAL
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1996-02-01 under 510(k) number K954848. The device is classified under product code MAL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT?

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1996-02-01. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K954848.

When did HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT receive FDA 510(k) clearance?

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT received FDA 510(k) clearance on 1996-02-01, under 510(k) number K954848.

Who is the listed applicant for HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT?

The FDA product code for HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT is MAL.

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 Meadox Medicals, Div. Boston Scientific Corp. 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.

K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGK960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTK962433MEADOX EXXCEL EPTFE VASCULAR GRAFTK961847HEMASHIELD VANTAGE (VASCULAR GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

View all 53 devices →

Related Devices (Code: MAL)

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.

K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLCK103080ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K093231ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K052302HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATIONBoston Scientific CorpK021213MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTSBoston Scientific Corp

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.

↑