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FDA 510(k)

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT

K-Number: K080379 · 2008-06-30

ApplicantMicrus Endovascular Corporation
Decision Date2008-06-30
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT is the device name listed in this FDA 510(k) record. The listed applicant is Micrus Endovascular Corporation. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K080379. 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 MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT?

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Micrus Endovascular Corporation. The 510(k) number is K080379.

When did MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT receive FDA 510(k) clearance?

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT received FDA 510(k) clearance on 2008-06-30, under 510(k) number K080379.

Who is the listed applicant for MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT?

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

What is the FDA product code for MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT?

The FDA product code for MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT is HCG.

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Other records listing Micrus Endovascular Corporation 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.

K103780MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIOK102818MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIREK092702MICRUS MICROCATHETER, MODEL COURIER 270K091504MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00K083922MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00K090274MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE

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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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