FDA 510(k)

ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER

K-Number: K844972 · 1985-05-16

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1985-05-16

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K844972. 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 ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER?

ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K844972.

When did ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER receive FDA 510(k) clearance?

ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER received FDA 510(k) clearance on 1985-05-16, under 510(k) number K844972.

Who is the listed applicant for ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER?

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

What is the FDA product code for ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER?

The FDA product code for ADV CARDIO SYS DBL LUMEN BALLOON DILATA 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Advanced Cardiovascular Systems, Inc. as applicant

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING K000550OTW MEGALINK SDS BILIARY STENT SYSTEM K994229VERIPATH PERIPHERAL GUIDING CATHETER K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

View all 103 devices →

Related Devices (Code: LIT)

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AG K252512Armada™ 14 NC PTA CatheterABBOTT MEDICAL K251915Amethyst 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.