510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945963Substantially Equivalent

The Omniguide Guiding Catheter with Balloon

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

K945963 is the FDA 510(k) clearance record for THE OMNIGUIDE GUIDING CATHETER WITH BALLOON, a class II device, cleared for Micro Interventional Systems, Inc. on under FDA product code DQT (Occluder, Catheter Tip). FDA records list one 510(k) clearance for Micro Interventional Systems, Inc. As of , FDA records show no recalls naming K945963.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DQT Occluder, Catheter Tip
Regulation
21 CFR 870.1370
Device class
Class II
Review panel
Cardiovascular
Applicant
Micro Interventional Systems, Inc. 680 W. Maude Ave., Sunnyvale CA
510(k) summary
Statement
Third party review
No

Clearances, product code DQT

Trailing 12 months

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

FDA records show no clearances under product code DQT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQT, 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