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)

ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE

K-Number: K861847 · 1986-06-16

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1986-06-16
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE 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 1986-06-16 under 510(k) number K861847. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE?

ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K861847.

When did ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE receive FDA 510(k) clearance?

ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861847.

Who is the listed applicant for ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE?

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 ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE?

The FDA product code for ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE is LOX.

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 Advanced Cardiovascular Systems, 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.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

View all 103 devices →

Related Devices (Code: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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.

↑