The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Modified Occluder/flushing Catheter Stopcock.
| Device ID | K875325 |
| 510k Number | K875325 |
| Device Name: | MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Ann Morrissey |
| Correspondent | Ann Morrissey SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-02-18 |