510(k) K191532

The Caterpillar and Caterpillar Micro Arterial Embolization Devices by C.R. Bard, Inc. — Product Code KRD

K191532 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "The Caterpillar and Caterpillar Micro Arterial Embolization Devices". The FDA issued a decision of Substantially Equivalent on Feb 4, 2020. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. C.R. Bard, Inc. has 645 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 4, 2020
Date Received
Jun 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type
510(k)