The following data is part of a premarket notification filed by Aesculap, Inc with the FDA for Aesculap Slim Clip Applier.
Device ID | K211572 |
510k Number | K211572 |
Device Name: | Aesculap Slim Clip Applier |
Classification | Applier, Aneurysm Clip |
Applicant | Aesculap, Inc 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Paul Amudala |
Correspondent | Paul Amudala Aesculap, Inc 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | HCI |
CFR Regulation Number | 882.4175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-21 |
Decision Date | 2021-12-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046964726835 | K211572 | 000 |
04046964725487 | K211572 | 000 |
04046964725494 | K211572 | 000 |
04046964725791 | K211572 | 000 |
04046964725807 | K211572 | 000 |
04046964725814 | K211572 | 000 |
04046964725821 | K211572 | 000 |
04046964725838 | K211572 | 000 |
04046964725845 | K211572 | 000 |
04046964725852 | K211572 | 000 |
04046964725869 | K211572 | 000 |
04046964725876 | K211572 | 000 |
04046964725883 | K211572 | 000 |
04046964725890 | K211572 | 000 |
04046964726804 | K211572 | 000 |
04046964726811 | K211572 | 000 |
04046964726828 | K211572 | 000 |
04046964725470 | K211572 | 000 |