MOF · Class II · 21 CFR 870.1330

FDA Product Code MOF: Guide, Wire, Catheter, Neurovasculature

Leading manufacturers include Asahi Intecc Co., Ltd., Scientia Vascular, Inc. and Arbor Endovascular, LLC.

40
Total
40
Cleared
127d
Avg days
2011
Since
40 devices
25–40 of 40
Cleared Mar 22, 2019
Aristotle 18 Guidewire, 200cm, Soft Profile
K183608
Scientia Vascular, LLC
Neurology · 86d
Cleared Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070
Asahi Intecc Co., Ltd.
Neurology · 85d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337
Balt USA, LLC
Neurology · 37d
Cleared Aug 07, 2018
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
K181828
Scientia Vascular, LLC
Neurology · 29d
Cleared Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K171613
Asahi Intecc Co., Ltd.
Neurology · 30d