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

Reprocessed Catheter Introducer

21 CFR 870.1340 / Cardiovascular
FDA source (opens on fda.gov)

PNE is the FDA product code for Reprocessed Catheter Introducer, a class II device type, regulated under 21 CFR 870.1340. FDA's definition for this code reads: "Introduce various cardiovascular catheters into the heart and cardiovascular system". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PNE
Device name
Reprocessed Catheter Introducer
FDA definition
Introduce various cardiovascular catheters into the heart and cardiovascular system
Regulation
21 CFR 870.1340
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
7
Ingested recalls
0

Clearances, product code PNE

By decision year
7 clearances under product code PNE with a decision year between 2016 and 2026, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PNE by decision year
YearClearances
20161
20171
20221
20231
20241
20251
20261

Applicants with the most clearances

Product code PNE
Applicants holding the most 510(k) clearances under product code PNE
ApplicantClearances
Innovative Health, LLC.5
Sterilmed Inc1
Medline ReNewal1

Companies listing this code with FDA

Companies whose registered establishments list this code