Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
FDA 510(k) K260105 · Edwards Lifesciences
510(k) numberK260105
Submission
- Device name
- Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- January 13, 2026
- Decision date
- June 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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Questions and answers
When was Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts cleared by the FDA?
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105) received a 510(k) decision of Substantially Equivalent on June 5, 2026, 143 days after the submission was received.
What is the product code of K260105?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.