FDA 510(k)

GDC STRETCH RESISTANT DETACHABLE COIL

K-Number: K030475 · 2003-03-14

Decision Date2003-03-14

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GDC STRETCH RESISTANT 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 2003-03-14 under 510(k) number K030475. 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 STRETCH RESISTANT DETACHABLE COIL?

GDC STRETCH RESISTANT DETACHABLE COIL is a medical device that received FDA 510(k) clearance on 2003-03-14. The listed applicant is Boston Scientific, Target. The 510(k) number is K030475.

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

GDC STRETCH RESISTANT DETACHABLE COIL received FDA 510(k) clearance on 2003-03-14, under 510(k) number K030475.

Who is the listed applicant for GDC STRETCH RESISTANT 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 GDC STRETCH RESISTANT DETACHABLE COIL?

The FDA product code for GDC STRETCH RESISTANT DETACHABLE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Boston Scientific, Target as applicant

K031049GUGLIELMI DETACHABLE COIL (GDC)K031168MATRIX STRETCH RESISTANT DETACHABLE COIL K022860ATLANTIS PV IMAGING CATHETER, MODEL 36456 K022357TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 K021494GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 K014109IN-TIME RETRIEVAL DEVICE

View all 19 devices →

Related Devices (Code: HCG)

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.