510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091780Substantially Equivalent

Guided Measurement Catheter (Gmc)

Mediguide, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091780 is the FDA 510(k) clearance record for GUIDED MEASUREMENT CATHETER (GMC), a class II device, cleared for Mediguide, Ltd. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 3 510(k) clearances for Mediguide, Ltd., from to . As of , FDA records show no recalls naming K091780.

Clearance record

Decision date
Received
(121 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Mediguide, Ltd. 555 Thirteenth St., NW, Washington DC
510(k) summary
Summary PDF
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