510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K230376Substantially Equivalent

Reprocessed Agilis NxT Steerable Introducer

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

K230376 is the FDA 510(k) clearance record for Reprocessed Agilis NxT Steerable Introducer, a class II device, cleared for Innovative Health, LLC on under FDA product code PNE (Reprocessed Catheter Introducer). FDA's definition for product code PNE reads: "Introduce various cardiovascular catheters into the heart and cardiovascular system". FDA records list 50 510(k) clearances for Innovative Health, LLC, from to . As of , FDA records show no recalls naming K230376.

Clearance record

Decision date
Received
(175 days to decision)
Product code
PNE Reprocessed Catheter Introducer
Regulation
21 CFR 870.1340
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 PNE

Trailing 12 months
2 clearances under product code PNE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260