510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061115Substantially Equivalent

Speedflow 0.2Um Filter, Model 11214; Speedflow 1.2Um Filter, Model 11215; Easydrop Controller, Model 11216

Gvs SpA, Manchester MI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061115 is the FDA 510(k) clearance record for SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216, a class II device, cleared for Gvs Spa on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Gvs Spa. As of , FDA records show no recalls naming K061115.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Gvs Spa 20171 Bowens Rd., Manchester MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260