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/WOVEN DOUBLE VELOUR FABRIC

K-Number: K931386 · 1993-05-27

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1993-05-27
Product CodeDXZ
Advisory CommitteeCV
DecisionUnknown

Device Summary

HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC 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 1993-05-27 under 510(k) number K931386. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC?

HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K931386.

When did HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC receive FDA 510(k) clearance?

HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC received FDA 510(k) clearance on 1993-05-27, under 510(k) number K931386.

Who is the listed applicant for HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC?

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/WOVEN DOUBLE VELOUR FABRIC?

The FDA product code for HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC is DXZ.

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: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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.

↑