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)

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

K-Number: K905773 · 1991-01-30

ApplicantMallinckrodt Medical
Decision Date1991-01-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905773. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER?

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Mallinckrodt Medical. The 510(k) number is K905773.

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

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905773.

Who is the listed applicant for PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER?

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

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

The FDA product code for PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 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 Mallinckrodt Medical 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.

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

View all 43 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.

↑