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FDA 510(k)

M-BOLUS EMBOLIC MICROSPHERES

K-Number: K052509 · 2006-12-11

ApplicantScion Cardio-Vascular, Inc.
Decision Date2006-12-11
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

M-BOLUS EMBOLIC MICROSPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Scion Cardio-Vascular, Inc.. It received FDA 510(k) clearance on 2006-12-11 under 510(k) number K052509. 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 M-BOLUS EMBOLIC MICROSPHERES?

M-BOLUS EMBOLIC MICROSPHERES is a medical device that received FDA 510(k) clearance on 2006-12-11. The listed applicant is Scion Cardio-Vascular, Inc.. The 510(k) number is K052509.

When did M-BOLUS EMBOLIC MICROSPHERES receive FDA 510(k) clearance?

M-BOLUS EMBOLIC MICROSPHERES received FDA 510(k) clearance on 2006-12-11, under 510(k) number K052509.

Who is the listed applicant for M-BOLUS EMBOLIC MICROSPHERES?

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

What is the FDA product code for M-BOLUS EMBOLIC MICROSPHERES?

The FDA product code for M-BOLUS EMBOLIC 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.

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Other records listing Scion Cardio-Vascular, Inc. 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.

K112961CLO-SURPLUS P.A.D.K092552CLO-SURPLUS P.A.D.K032986CLO-SURPLUSP.A.D.

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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