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FDA 510(k)

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

K-Number: K260105 · 2026-06-05

ApplicantEdwards Lifesciences
Decision Date2026-06-05
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260105. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Edwards Lifesciences. The 510(k) number is K260105.

When did Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts receive FDA 510(k) clearance?

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260105.

Who is the listed applicant for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

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

What is the FDA product code for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

The FDA product code for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is DXC.

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04614402Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences as applicant

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Related Devices (Code: DXC)

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.

K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LPK232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,LtdK230281PICOCLAMPKono Seisakusho Co., Ltd.

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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