510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K942503Substantially Equivalent

Unicath Family

Angiographic Devices Corp., Littleton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942503 is the FDA 510(k) clearance record for UNICATH FAMILY, a class II device, cleared for Angiographic Devices Corp. on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list one 510(k) clearance for Angiographic Devices Corp. As of , FDA records show no recalls naming K942503.

Clearance record

Decision date
Received
(55 days to decision)
Product code
IZI System, X-Ray, Angiographic
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
Angiographic Devices Corp. 300 Foster St., Littleton MA
510(k) summary
Statement
Third party review
No

Clearances, product code IZI

Trailing 12 months
2 clearances under product code IZI in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260