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)

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES

K-Number: K042297 · 2005-06-01

ApplicantActa Vascular Systems, Inc.
Decision Date2005-06-01
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Acta Vascular Systems, Inc.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K042297. 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 ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES?

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Acta Vascular Systems, Inc.. The 510(k) number is K042297.

When did ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES receive FDA 510(k) clearance?

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES received FDA 510(k) clearance on 2005-06-01, under 510(k) number K042297.

Who is the listed applicant for ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES?

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

What is the FDA product code for ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES?

The FDA product code for ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES 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

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

View on FDA Database →

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

↑