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FDA 510(k)

IVALON EMBOLIZATION PARTICLES

K-Number: K913556 · 1994-04-13

ApplicantIvalon
Decision Date1994-04-13
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IVALON EMBOLIZATION PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Ivalon. It received FDA 510(k) clearance on 1994-04-13 under 510(k) number K913556. 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 IVALON EMBOLIZATION PARTICLES?

IVALON EMBOLIZATION PARTICLES is a medical device that received FDA 510(k) clearance on 1994-04-13. The listed applicant is Ivalon. The 510(k) number is K913556.

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

IVALON EMBOLIZATION PARTICLES received FDA 510(k) clearance on 1994-04-13, under 510(k) number K913556.

Who is the listed applicant for IVALON EMBOLIZATION PARTICLES?

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

What is the FDA product code for IVALON EMBOLIZATION PARTICLES?

The FDA product code for IVALON 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.

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Other records listing Ivalon 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.

K946016IVALON OPHTHALMIC SPONGEK946015IVALON EXTERNAL SPONGE

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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