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FDA 510(k)

QUADRASPHERE 30 TO 60

K-Number: K113822 · 2012-03-08

ApplicantBiosphere Medical, Inc.
Decision Date2012-03-08
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QUADRASPHERE 30 TO 60 is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, Inc.. It received FDA 510(k) clearance on 2012-03-08 under 510(k) number K113822. 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 QUADRASPHERE 30 TO 60?

QUADRASPHERE 30 TO 60 is a medical device that received FDA 510(k) clearance on 2012-03-08. The listed applicant is Biosphere Medical, Inc.. The 510(k) number is K113822.

When did QUADRASPHERE 30 TO 60 receive FDA 510(k) clearance?

QUADRASPHERE 30 TO 60 received FDA 510(k) clearance on 2012-03-08, under 510(k) number K113822.

Who is the listed applicant for QUADRASPHERE 30 TO 60?

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

What is the FDA product code for QUADRASPHERE 30 TO 60?

The FDA product code for QUADRASPHERE 30 TO 60 is HCG.

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Other records listing Biosphere Medical, 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.

K052742HEPASPHERE MICROSPHERESK062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXK021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONK010026EMBOGOLD MICROSPHERE

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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