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FDA 510(k)

EMBOSPHERE MICROSPHERES

K-Number: K991549 · 2000-04-26

ApplicantBiosphere Medical
Decision Date2000-04-26
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMBOSPHERE MICROSPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical. It received FDA 510(k) clearance on 2000-04-26 under 510(k) number K991549. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOSPHERE MICROSPHERES?

EMBOSPHERE MICROSPHERES is a medical device that received FDA 510(k) clearance on 2000-04-26. The listed applicant is Biosphere Medical. The 510(k) number is K991549.

When did EMBOSPHERE MICROSPHERES receive FDA 510(k) clearance?

EMBOSPHERE MICROSPHERES received FDA 510(k) clearance on 2000-04-26, under 510(k) number K991549.

Who is the listed applicant for EMBOSPHERE MICROSPHERES?

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 EMBOSPHERE MICROSPHERES?

The FDA product code for EMBOSPHERE MICROSPHERES is HCG.

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.

K003105BIOSPHERE MEDICAL INFUSION CATHETER

Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

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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