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FDA 510(k)

TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM

K-Number: K093142 · 2010-02-04

ApplicantBoston Scientific Corp
Decision Date2010-02-04
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K093142. 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 TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM?

TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Boston Scientific Corp. The 510(k) number is K093142.

When did TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM receive FDA 510(k) clearance?

TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM received FDA 510(k) clearance on 2010-02-04, under 510(k) number K093142.

Who is the listed applicant for TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM?

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

What is the FDA product code for TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM?

The FDA product code for TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM is HCG.

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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.

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