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)

GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL

K-Number: K042539 · 2004-10-19

ApplicantBoston Scientific Corp
Decision Date2004-10-19
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042539. 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 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL?

GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K042539.

When did GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL receive FDA 510(k) clearance?

GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042539.

Who is the listed applicant for GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL?

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

What is the FDA product code for GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL?

The FDA product code for GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL 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 Corp 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 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.

↑