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

Catheter, Intracardiac Mapping, High-Density, Reprocessed

21 CFR 870.1220 / Cardiovascular
FDA source (opens on fda.gov)

NLG is the FDA product code for Catheter, Intracardiac Mapping, High-Density, Reprocessed, a class II device type, regulated under 21 CFR 870.1220. FDA's definition for this code reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NLG
Device name
Catheter, Intracardiac Mapping, High-Density, Reprocessed
FDA definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 870.1220
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
3
Ingested recalls
0

Clearances, product code NLG

By decision year
3 clearances under product code NLG with a decision year between 2019 and 2021, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NLG by decision year
YearClearances
20191
20212

Applicants with the most clearances

Product code NLG
Applicants holding the most 510(k) clearances under product code NLG
ApplicantClearances
Innovative Health, LLC.3

Companies listing this code with FDA

Companies whose registered establishments list this code