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 |