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FDA 510(k)

Target Tetra Detachable Coils

K-Number: K222533 · 2022-12-14

ApplicantStryker Neurovascular
Decision Date2022-12-14
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Target Tetra Detachable Coils is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K222533. 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 Target Tetra Detachable Coils?

Target Tetra Detachable Coils is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Stryker Neurovascular. The 510(k) number is K222533.

When did Target Tetra Detachable Coils receive FDA 510(k) clearance?

Target Tetra Detachable Coils received FDA 510(k) clearance on 2022-12-14, under 510(k) number K222533.

Who is the listed applicant for Target Tetra Detachable Coils?

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

What is the FDA product code for Target Tetra Detachable Coils?

The FDA product code for Target Tetra Detachable Coils 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.

NCT04057352Citadel Embolization Device StudyACTIVE_NOT_RECRUITINGNCT04195568Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemACTIVE_NOT_RECRUITING

Other records listing Stryker Neurovascular 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.

K261889Trevo Trak 21 MicrocatheterPMA P170024Intracranial aneurysm flow diverterK253032AXS Lift Intracranial Base CatheterK252694Target Detachable CoilK251832InZone IST Detachment System; IZDS Connecting CablePMA P180031Intracranial coil-assist stent

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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.

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