510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160421Substantially Equivalent

Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter

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

K160421 is the FDA 510(k) clearance record for Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter, a class II device, cleared for Innovative Health, LLC on under FDA product code NLH (Catheter, Recording, Electrode, Reprocessed). FDA's definition for product code NLH 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 K160421.

Clearance record

Decision date
Received
(260 days to decision)
Product code
NLH Catheter, Recording, Electrode, 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 NLH

Trailing 12 months
1 clearance under product code NLH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NLH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260