510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901562Substantially Equivalent

Cvis Insight Imaging Catheter

Cardiovascular Imaging Systems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901562 is the FDA 510(k) clearance record for CVIS INSIGHT IMAGING CATHETER, a class II device, cleared for Cardiovascular Imaging Systems, Inc. on under FDA product code DXK (Echocardiograph). FDA records list 19 510(k) clearances for Cardiovascular Imaging Systems, Inc., from to . As of , FDA records show no recalls naming K901562.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiovascular Imaging Systems, Inc. 595 N. Pastoria Ave., Sunnyvale CA
Third party review
No

Clearances, product code DXK

Trailing 12 months

FDA records hold no clearances under product code DXK in the trailing twelve months.

FDA records show no clearances under product code DXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260