510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100635Substantially Equivalent

Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504

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

K100635 is the FDA 510(k) clearance record for ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504, a class II device, cleared for Arrow Intl., Inc. on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K100635.

Clearance record

Decision date
Received
(175 days to decision)
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Arrow Intl., Inc. 2400 Bernville Rd., Reading PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJS

Trailing 12 months
3 clearances under product code LJS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260