510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163693Substantially Equivalent

IntraClude Intra-Aortic Occlusion Device

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

K163693 is the FDA 510(k) clearance record for IntraClude Intra-Aortic Occlusion Device, 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 3 recalls naming K163693.

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 One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXC

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