Submission Details
| 510(k) Number | K191532 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2019 |
| Decision Date | February 04, 2020 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
Feb 2020
Decision
239d
Days
Class 2
Risk
About This 510(k) Submission
K191532 is an FDA 510(k) clearance for the The Caterpillar and Caterpillar Micro Arterial Embolization Devices, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by C.R. Bard, Inc. (Enniscorthy, IE). The FDA issued a Cleared decision on February 4, 2020, 239 days after receiving the submission on June 10, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.
Device Classification
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3300 |
Manufacturer
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