The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Insitucat Valve Stripper.
Device ID | K885046 |
510k Number | K885046 |
Device Name: | INSITUCAT VALVE STRIPPER |
Classification | Stripper, Vein, External |
Applicant | AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Contact | Robin Bush |
Correspondent | Robin Bush AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Product Code | DWQ |
CFR Regulation Number | 870.4885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-05 |
Decision Date | 1990-02-28 |