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FDA 510(k)

SAPPHIRE NXT DETACHABLE COIL SYSTEM

K-Number: K041649 · 2004-07-16

ApplicantMicro Therapeutics, Inc.
Decision Date2004-07-16
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE NXT DETACHABLE COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041649. 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 SAPPHIRE NXT DETACHABLE COIL SYSTEM?

SAPPHIRE NXT DETACHABLE COIL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K041649.

When did SAPPHIRE NXT DETACHABLE COIL SYSTEM receive FDA 510(k) clearance?

SAPPHIRE NXT DETACHABLE COIL SYSTEM received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041649.

Who is the listed applicant for SAPPHIRE NXT DETACHABLE COIL SYSTEM?

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

What is the FDA product code for SAPPHIRE NXT DETACHABLE COIL SYSTEM?

The FDA product code for SAPPHIRE NXT DETACHABLE COIL SYSTEM is HCG.

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Other records listing Micro Therapeutics, 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.

K113289ORION MICRO CATHETERK11345414 WIRE STANDARD, 14 WIRE LSK090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORYK090046CONCERTO DETACHABLE COIL SYSTEMK081465AXIUM DETACHABLE COIL SYSTEMK060747FX DETACHABLE COIL SYSTEM

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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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