510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212776Substantially Equivalent

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Innovative Health, LLC., Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212776 is the FDA 510(k) clearance record for Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, a class II device, cleared for Innovative Health, LLC on under FDA product code NLG (Catheter, Intracardiac Mapping, High-Density, Reprocessed). FDA's definition for product code NLG 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)". FDA records list 50 510(k) clearances for Innovative Health, LLC, from to . As of , FDA records show no recalls naming K212776.

Clearance record

Decision date
Received
(110 days to decision)
Product code
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Innovative Health, LLC 1435 N. Hayden Rd., Scottsdale AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLG

Trailing 12 months

FDA records hold no clearances under product code NLG in the trailing twelve months.

FDA records show no clearances under product code NLG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260