Medical Device Manufacturer · US , Findley , MN

Microvena Corp. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1990

Recent clearances: ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE, MODIFICATION TO ULTRA-SELECT GUIDEWIRE, AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Microvena Corp. Cardiovascular ✕

18 devices

1-12 of 18

Cleared Jun 16, 1999

ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE

Cardiovascular · 12d

Cleared May 05, 1999

MODIFICATION TO ULTRA-SELECT GUIDEWIRE

Cardiovascular · 27d

Cleared Nov 18, 1998

AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT...

Cardiovascular · 111d

Cleared Jun 10, 1998

THE AMPLANTZ GOOSE NECK MICROSNARE

Cardiovascular · 471d

Cleared Mar 06, 1998

AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

Cardiovascular · 246d

Cleared Sep 19, 1997

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

Cardiovascular · 113d

Cleared Dec 17, 1996

HYDRO-SELECT GUIDEWIRE

Cardiovascular · 434d

Cleared Aug 13, 1996

THE AMPLATZ THROMBECTOMY DEVICE

Cardiovascular · 341d

Cleared May 16, 1996

Cardiovascular · 178d

Cleared Dec 13, 1995

THE NINER NITINOL GUIDEWIRE

Cardiovascular · 174d

Cleared Mar 31, 1995

M-PATH NITINOL GUIDEWIRE

Cardiovascular · 91d

Cleared Sep 24, 1993

Cardiovascular · 331d