The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Ace 68 Reperfusion Catheter.
Device ID | K161640 |
510k Number | K161640 |
Device Name: | Penumbra System ACE 68 Reperfusion Catheter |
Classification | Catheter, Thrombus Retriever |
Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
Contact | Charles Denault |
Correspondent | Charles Denault Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
Product Code | NRY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-14 |
Decision Date | 2016-07-12 |
Summary: | summary |