510(k) K191532
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)