The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for The Caterpillar And Caterpillar Micro Arterial Embolization Devices.
| Device ID | K191532 |
| 510k Number | K191532 |
| Device Name: | The Caterpillar And Caterpillar Micro Arterial Embolization Devices |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | C. R. Bard, Inc. Moyne Upper Emniscorthy, IE |
| Contact | Melanie Hadlock |
| Correspondent | Melanie Hadlock C. R. Bard, Inc. Moyne Upper Emniscorthy, IE |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2020-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741175565 | K191532 | 000 |
| 00801741155307 | K191532 | 000 |
| 00801741155314 | K191532 | 000 |