# K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce - Pathway: 510(k) (Traditional) - Applicant: Target Therapeutics - Decided: Jul 14, 1997 after 90 days - Product code: DQX (Wire, Guide, Catheter) - Device class: 2 - Regulation: 21 CFR 870.1330 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K951256 (1995). 21 ancestors in all. 150 later devices descend from it; 5 cite it directly. 1 of 172 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 1. - K925813: Diagnostic Intravascular Catheter, Target Therapeutics (1994) Summary page 1. - K950069: Dasher-14, Target Therapeutics (1995) Summary page 1. - K915115: Guider Dasher, Target Therapeutics (1992) Summary page 1. - K924987: Taper Guidewires, Target Therapeutics (1992) Summary page 1. - K880762: Taper Flex-Tip Steerable Guidewire, Target Therapeutics (1988) Summary page 1. - K912293: Remove Labeling Restrict From Guide Wires, Target Therapeutics (1991) Summary page 1. - K922912: Seeker Lite - 10, Target Therapeutics (1992) Summary page 1. - K915895: Stealth Dilation Catheter System (Modified), Target Therapeutics (1992) Summary page 1. - K955293: Fibered Platinum Coil, .035 Type, Target Therapeutics (1996) Summary page 1. - K964112: Berenstein Coil, Target Therapeutics (1997) Summary page 1. - K914786: Target Therapeutics Coils, Target Therapeutics (1992) Summary page 1. - K873971: Rotating Hemostatic Valve, Target Therapeutics (1988) Summary page 1. - K873972: Guide Wire Introducer, Target Therapeutics (1988) Summary page 1. - K860840: Guided Wire Torquer, Target Therapeutics (1986) Summary page 1. - K911779: Helix Shaped Coils with Dacron Fibers, Modified, Target Therapeutics (1991) Summary page 1. - K891688: Coil and Coil Delivery System, Target Therapeutics (1989) Summary page 1. - K951159: Fasguide, Target Therapeutics (1995) Summary page 1. ## Cited in the summary but kept off the family tree - K090428: Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AC, Genesee Biomedical, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K991139: Guglielmi Detachable (GDC) (1999), 138 descendants of its own - K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1 (2000), 105 descendants of its own - K022420: Micrus Stretch-Resistant Microcoil System, MSR01 (2002), 103 descendants of its own - K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC) (2000), 98 descendants of its own - K012145: Microplex Coil System (2001), 96 descendants of its own ## Indications for use For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team-to-be a) very high risk for management by traditionat-operative techniques, or byinoperable; and-for embolizing other vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous enbolizations in the peripheral vasculature. For arterial and venous embolizations in the peripheral vasculature For the embolization of vascular malformations of the peripheral, coronary an neuro vasculature. Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are intended for use in the interventional rediologic management of arteriovenous mafformations and arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable. Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion Catheters to selected vascular sites. Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. The Stealth Dilatation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This device is no intended for use in the coronary arteries. The coil pusher is a guidewire-like device consisting of a stainless stee! wire with a radiopaque gold marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site. The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs or hemostatic valves. The guidewire torquer was developed to enhance contro! of torqueable guidewires during intravascular placement. To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the placement of a therapeutic or diagnostic catheter. The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a catheter tip to suit the requirements of a particular case. The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the balloon section enabling it to be inflated. Source page: https://510kreport.com/device/K971395 Methodology: https://510kreport.com/methodology