510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K113622Substantially Equivalent

Orion II CT Cvc

Health Line International Corporation (Hlic), Centerville UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113622 is the FDA 510(k) clearance record for ORION II CT CVC, a class II device, cleared for Health Line International Corporation (Hlic) on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 2 510(k) clearances for Health Line International Corporation (Hlic), from to . As of , FDA records show no recalls naming K113622.

Clearance record

Decision date
Received
(162 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Health Line International Corporation (Hlic) 803 N. 1250 W., Centerville UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260