GDC Patient Return Electtrode Model 45021

FDA 510(k) K963307 · Target Therapeutics

Substantially Equivalent

510(k) numberK963307

Submission

Device name
GDC Patient Return Electtrode Model 45021
Applicant
Target Therapeutics
Freemont, CA, US
Received
August 22, 1996
Decision date
December 17, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCG – Device, Neurovascular Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code HCG

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K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special Cerenovus, Inc.08/14/2026SE
K261772Target Xtra Detachable CoilHCG · Special Stryker Neurovscular06/24/2026SE
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.05/20/2026SE
K254221Optima Coil System (OptiOne Coil System)HCG · Special Balt USA, LLC01/27/2026SE
K252694Target Detachable CoilHCG · Traditional Stryker Neurovascular12/11/2025SE
K251832InZone IST Detachment System; IZDS Connecting CableHCG · Special Stryker Neurovascular10/17/2025SE
K252700Optima Coil System (Optima Packing Coil System)HCG · Special Balt USA, LLC09/26/2025SE
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.09/30/2024SE
K242582Optima Coil System (OptiBlock Line Extension)HCG · Special Balt USA, LLC09/27/2024SE
K242243Target Detachable CoilsHCG · Special Stryker Neurovscular08/29/2024SE

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K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional 07/14/1997SE
K965189SpinnakerKRA · Traditional 03/24/1997SE
K964112Berenstein CoilKRD · Traditional 02/26/1997SE
K962503Guglielmi Detachable CoilHCG · Traditional 09/20/1996SE
K961923Berenstein CoilHCG · Traditional 08/15/1996SE
K960705Guglielmi Detachable CoilHCG · Traditional 05/21/1996SE
K960806Turbo TrackerDQO · Traditional 05/02/1996SE

Questions and answers

When was GDC Patient Return Electtrode Model 45021 cleared by the FDA?

GDC Patient Return Electtrode Model 45021 (K963307) received a 510(k) decision of Substantially Equivalent on December 17, 1996, 117 days after the submission was received.

What is the product code of K963307?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.