Mallinckroot, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
5 devices
Cleared
Apr 16, 1999
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
Cardiovascular
168d
Cleared
Oct 02, 1989
MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
Cardiovascular
77d
Cleared
May 15, 1989
A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
Cardiovascular
138d
Cleared
Feb 22, 1989
SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
Cardiovascular
141d
Cleared
Jan 10, 1989
CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
Cardiovascular
80d