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 |