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)

PVA FOAM EMBOLIZATION PARTICLES

K-Number: K001678 · 2001-01-25

ApplicantSurgica Corp.
Decision Date2001-01-25
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PVA FOAM EMBOLIZATION PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Surgica Corp.. It received FDA 510(k) clearance on 2001-01-25 under 510(k) number K001678. 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 PVA FOAM EMBOLIZATION PARTICLES?

PVA FOAM EMBOLIZATION PARTICLES is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Surgica Corp.. The 510(k) number is K001678.

When did PVA FOAM EMBOLIZATION PARTICLES receive FDA 510(k) clearance?

PVA FOAM EMBOLIZATION PARTICLES received FDA 510(k) clearance on 2001-01-25, under 510(k) number K001678.

Who is the listed applicant for PVA FOAM EMBOLIZATION PARTICLES?

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

What is the FDA product code for PVA FOAM EMBOLIZATION PARTICLES?

The FDA product code for PVA FOAM 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

Other records listing Surgica Corp. 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.

K032619MICROSTAT PVA FOAM EMBOLIZATION PARTICLESK020033MAXISTAT PVA FOAM EMBOLIZATION PARTICLES

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.

↑