Cleared Traditional

K260105 - Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

K260105 is an FDA 510(k) clearance for Fogarty Spring Clips, manufactured by Edwards Lifesciences. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K260105 · Edwards Lifesciences · Cardiovascular device
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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

FDA 510(k) Submission Details - K260105

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.

DXC Device Classification - Class 2, Special Controls

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 150
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