Cleared Traditional

K260105 - Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260105 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
143d
Days
Class 2
Risk

K260105 is an FDA 510(k) clearance for the Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on June 5, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences devices

Submission Details

510(k) Number K260105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2026
Decision Date June 05, 2026
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 203
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K260105.
Arc Adjustable Radial Cuff Compression Device
K252772 · Tz Medical, Inc. · May 2026
Life Saving Tourniquet
K254060 · TW Medical · Apr 2026
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023