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)

BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER

K-Number: K930745 · 1994-05-19

ApplicantB.Braun Medical, Inc.
Decision Date1994-05-19
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1994-05-19 under 510(k) number K930745. 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 BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER?

BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER is a medical device that received FDA 510(k) clearance on 1994-05-19. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K930745.

When did BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER receive FDA 510(k) clearance?

BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER received FDA 510(k) clearance on 1994-05-19, under 510(k) number K930745.

Who is the listed applicant for BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER?

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

What is the FDA product code for BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER?

The FDA product code for BURRON EXPEDITER BRAIDED BALLOON PTA 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 B.Braun Medical, 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.

K254111Irrigation/Urology SetsK253235Introcan Safety® Deep Access XL IV CatheterK243392Infusomat® Space Volumetric Infusion Pump Administration SetsK240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemK241845Introcan Safety® 2 IV CatheterK241385Omnifix Syringe NRFit

View all 142 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.

↑