510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213838Substantially Equivalent

AneuGuide

ArteryFlow Technology Co., Ltd., Hangzhou City, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213838 is the FDA 510(k) clearance record for AneuGuide, a class II device, cleared for ArteryFlow Technology Co., Ltd. on under FDA product code PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices). FDA's definition for product code PZO reads: "Visualization and measurement of blood vessels and intravascular devices for preoperational planning". FDA records list 6 510(k) clearances for ArteryFlow Technology Co., Ltd., from to . As of , FDA records show no recalls naming K213838.

Clearance record

Decision date
Received
(174 days to decision)
Product code
PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
ArteryFlow Technology Co., Ltd. 459 Qianmo Rd., Suite C1-501, Binjiang District, Hangzhou City, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZO

Trailing 12 months
1 clearance under product code PZO 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 PZO, 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