510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K112694Substantially Equivalent

Edwards Lifesciences Endoclamp Aortic Catheter

Edwards Lifesciences LLC, Draper UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112694 is the FDA 510(k) clearance record for EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code DXC (Clamp, Vascular). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K112694.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy., Draper UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXC

Trailing 12 months
5 clearances under product code DXC in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260