Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GUGLIELMI DETACHABLE COIL (GDC)

K-Number: K031049 · 2003-08-01

ApplicantBoston Scientific, Target
Decision Date2003-08-01
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GUGLIELMI DETACHABLE COIL (GDC) 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 2003-08-01 under 510(k) number K031049. 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 GUGLIELMI DETACHABLE COIL (GDC)?

GUGLIELMI DETACHABLE COIL (GDC) is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Boston Scientific, Target. The 510(k) number is K031049.

When did GUGLIELMI DETACHABLE COIL (GDC) receive FDA 510(k) clearance?

GUGLIELMI DETACHABLE COIL (GDC) received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031049.

Who is the listed applicant for GUGLIELMI DETACHABLE COIL (GDC)?

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 GUGLIELMI DETACHABLE COIL (GDC)?

The FDA product code for GUGLIELMI DETACHABLE COIL (GDC) is HCG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

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: 451007-4K014109IN-TIME RETRIEVAL DEVICE

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.

↑