510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K152633Substantially Equivalent

Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe

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

K152633 is the FDA 510(k) clearance record for Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K152633.

Clearance record

Decision date
Received
(30 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
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 LDF

Trailing 12 months
1 clearance under product code LDF in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260