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

Device For Open Surgical Explant Of Endovascular Prostheses

21 CFR 870.4520 / Cardiovascular
FDA source (opens on fda.gov)

SHR is the FDA product code for Device For Open Surgical Explant Of Endovascular Prostheses, a class II device type, regulated under 21 CFR 870.4520. FDA's definition for this code reads: "This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHR
Device name
Device For Open Surgical Explant Of Endovascular Prostheses
FDA definition
This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
Regulation
21 CFR 870.4520
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SHR

By decision year
1 clearance under product code SHR with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHR by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHR
Applicants holding the most 510(k) clearances under product code SHR
ApplicantClearances
Hjarta Care, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code