510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904618Substantially Equivalent

Cvis Insight Imaging Catheter

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

K904618 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 DQO (Catheter, Intravascular, Diagnostic). FDA records list 19 510(k) clearances for Cardiovascular Imaging Systems, Inc., from to . As of , FDA records show no recalls naming K904618.

Clearance record

Decision date
Received
(183 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
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 DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260