510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K141618Substantially Equivalent

Arrow Vps Stylet Plus and Cg+ Arrow Picc Powered by Arrow Vps Stylet Plus

Arrow International, Inc (Subsidiary of Teleflex I, Reading PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141618 is the FDA 510(k) clearance record for ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS, a class II device, cleared for Arrow International, Inc (Subsidiary of Teleflex I on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list one 510(k) clearance for Arrow International, Inc (Subsidiary of Teleflex I. As of , FDA records show no recalls naming K141618.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow International, Inc (Subsidiary of Teleflex I 2400 Bernville Rd., Reading PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBJ

Trailing 12 months
4 clearances under product code OBJ 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 OBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260