510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN250033Unknown

XplantR Explant Tool

Hjarta Care, LLC, Waukesha WI / Direct, Unknown
FDA source (opens on fda.gov)

DEN250033 is the FDA 510(k) clearance record for XplantR Explant Tool, a class II device, cleared for Hjarta Care, LLC on under FDA product code SHR (Device For Open Surgical Explant Of Endovascular Prostheses). FDA's definition for product code SHR reads: "This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels". FDA records list one 510(k) clearance for Hjarta Care, LLC. As of , FDA records show no recalls naming DEN250033.

Clearance record

Decision date
Received
(253 days to decision)
Product code
SHR Device For Open Surgical Explant Of Endovascular Prostheses
Regulation
21 CFR 870.4520
Device class
Class II
Review panel
Cardiovascular
Applicant
Hjarta Care, LLC N16 W23233 Stone Ridge Dr., Waukesha WI
Third party review
No

Clearances, product code SHR

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