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FDA 510(k)

DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

K-Number: K000651 · 2000-11-24

ApplicantCook, Inc.
Decision Date2000-11-24
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2000-11-24 under 510(k) number K000651. 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 DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM?

DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Cook, Inc.. The 510(k) number is K000651.

When did DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM receive FDA 510(k) clearance?

DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM received FDA 510(k) clearance on 2000-11-24, under 510(k) number K000651.

Who is the listed applicant for DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM?

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

What is the FDA product code for DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM?

The FDA product code for DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM is HCG.

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Other records listing Cook, Inc. as applicant

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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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