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FDA 510(k)

FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL

K-Number: K993418 · 2000-01-21

ApplicantBoston Scientific, Target
Decision Date2000-01-21
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific, Target. It received FDA 510(k) clearance on 2000-01-21 under 510(k) number K993418. 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 FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL?

FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL is a medical device that received FDA 510(k) clearance on 2000-01-21. The listed applicant is Boston Scientific, Target. The 510(k) number is K993418.

When did FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL receive FDA 510(k) clearance?

FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL received FDA 510(k) clearance on 2000-01-21, under 510(k) number K993418.

Who is the listed applicant for FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL?

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

What is the FDA product code for FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL?

The FDA product code for FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL is HCG.

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Other records listing Boston Scientific, Target 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.

K031049GUGLIELMI DETACHABLE COIL (GDC)K031168MATRIX STRETCH RESISTANT DETACHABLE COILK030475GDC STRETCH RESISTANT DETACHABLE COILK022860ATLANTIS PV IMAGING CATHETER, MODEL 36456K022357TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815K021494GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4

View all 19 devices →

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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