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)

MEADOX SURGIMED BALLOON CATHETER

K-Number: K923947 · 1993-09-30

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1993-09-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEADOX SURGIMED BALLOON CATHETER 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 1993-09-30 under 510(k) number K923947. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEADOX SURGIMED BALLOON CATHETER?

MEADOX SURGIMED BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1993-09-30. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K923947.

When did MEADOX SURGIMED BALLOON CATHETER receive FDA 510(k) clearance?

MEADOX SURGIMED BALLOON CATHETER received FDA 510(k) clearance on 1993-09-30, under 510(k) number K923947.

Who is the listed applicant for MEADOX SURGIMED BALLOON CATHETER?

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 MEADOX SURGIMED BALLOON CATHETER?

The FDA product code for MEADOX SURGIMED BALLOON CATHETER is LIT.

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: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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.

↑