510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171483Substantially Equivalent

ArchFlo CT Midline

Medcomp (dba Medical Components, Inc.), Harleysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171483 is the FDA 510(k) clearance record for ArchFlo CT Midline, a class II device, cleared for Medcomp (Dba Medical Components, 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 3 510(k) clearances for Medcomp (Dba Medical Components, Inc.), from to . As of , FDA records show no recalls naming K171483.

Clearance record

Decision date
Received
(207 days to decision)
Product code
PND Midline Catheter
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Medcomp (Dba Medical Components, Inc.) 1499 Delp Dr., Harleysville 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