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)

WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

K-Number: K991540 · 1999-09-29

ApplicantAngioDynamics, Inc.
Decision Date1999-09-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 1999-09-29 under 510(k) number K991540. 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 WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER?

WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1999-09-29. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K991540.

When did WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER receive FDA 510(k) clearance?

WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER received FDA 510(k) clearance on 1999-09-29, under 510(k) number K991540.

Who is the listed applicant for WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER?

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

What is the FDA product code for WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER?

The FDA product code for WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 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 AngioDynamics, 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.

K252509AlphaVac Multipurpose Mechanical Aspiration System F1885K253106AngioVac CannulaK242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsK223581Solero Microwave Tissue Ablation (MTA) System and Accessories

View all 82 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.

↑