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FDA 510(k)

BIOSPHERE MEDICAL INFUSION CATHETER

K-Number: K003105 · 2001-05-22

ApplicantBiosphere Medical
Decision Date2001-05-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSPHERE MEDICAL INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical. It received FDA 510(k) clearance on 2001-05-22 under 510(k) number K003105. 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 BIOSPHERE MEDICAL INFUSION CATHETER?

BIOSPHERE MEDICAL INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2001-05-22. The listed applicant is Biosphere Medical. The 510(k) number is K003105.

When did BIOSPHERE MEDICAL INFUSION CATHETER receive FDA 510(k) clearance?

BIOSPHERE MEDICAL INFUSION CATHETER received FDA 510(k) clearance on 2001-05-22, under 510(k) number K003105.

Who is the listed applicant for BIOSPHERE MEDICAL INFUSION CATHETER?

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

What is the FDA product code for BIOSPHERE MEDICAL INFUSION CATHETER?

The FDA product code for BIOSPHERE MEDICAL INFUSION CATHETER 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_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 Biosphere 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.

K991549EMBOSPHERE MICROSPHERES

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal 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 VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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