510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161313Substantially Equivalent

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

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

K161313 is the FDA 510(k) clearance record for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology, a class II device, cleared for Arrow International, Inc. (Subsidiary of Teleflex, Inc.) on under FDA product code PND (Midline Catheter). FDA's definition for product code PND reads: "The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days". FDA records list 10 510(k) clearances for Arrow International, Inc. (Subsidiary of Teleflex, Inc.), from to . As of , FDA records show 2 recalls naming K161313.

Clearance record

Decision date
Received
(106 days to decision)
Product code
PND Midline Catheter
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) 2400 Bernville Rd., Reading PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PND

Trailing 12 months
1 clearance under product code PND 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 PND, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260