510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200060Substantially Equivalent

Reprocessed NRG Transseptal Needle

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

K200060 is the FDA 510(k) clearance record for Reprocessed NRG Transseptal Needle, a class II device, cleared for Innovative Health, LLC on under FDA product code QLZ (Septostomy Catheter, Reprocessed). FDA's definition for product code QLZ reads: "To create or enlarge an atrial septal defect in the heart". FDA records list 50 510(k) clearances for Innovative Health, LLC, from to . As of , FDA records show no recalls naming K200060.

Clearance record

Decision date
Received
(199 days to decision)
Product code
QLZ Septostomy Catheter, Reprocessed
Regulation
21 CFR 870.5175
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 QLZ

Trailing 12 months

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

FDA records show no clearances under product code QLZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QLZ, 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