The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella Cp Introducer.
| Device ID | K192769 |
| 510k Number | K192769 |
| Device Name: | Impella CP Introducer |
| Classification | Introducer, Catheter |
| Applicant | Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Contact | Robert Stewart |
| Correspondent | Robert Stewart Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813502011715 | K192769 | 000 |
| 00813502011708 | K192769 | 000 |
| 00813502011661 | K192769 | 000 |
| 00813502011654 | K192769 | 000 |
| 00813502011500 | K192769 | 000 |
| 00813502011302 | K192769 | 000 |
| 00813502010015 | K192769 | 000 |
| 00813502013474 | K192769 | 000 |