FDA 510(k)

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135

K-Number: K062126 · 2006-08-09

Decision Date2006-08-09

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, Inc.. It received FDA 510(k) clearance on 2006-08-09 under 510(k) number K062126. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135?

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 is a medical device that received FDA 510(k) clearance on 2006-08-09. The listed applicant is Biosphere Medical, Inc.. The 510(k) number is K062126.

When did EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 receive FDA 510(k) clearance?

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 received FDA 510(k) clearance on 2006-08-09, under 510(k) number K062126.

Who is the listed applicant for EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135?

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

What is the FDA product code for EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135?

The FDA product code for EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 is DQO.

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 Biosphere Medical, Inc. as applicant

K113822QUADRASPHERE 30 TO 60 K052742HEPASPHERE MICROSPHERES K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX K021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION K010026EMBOGOLD MICROSPHERE

Related Devices (Code: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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.