The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Hemostasis Valve, With Or Without Side Port.
| Device ID | K890277 |
| 510k Number | K890277 |
| Device Name: | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT |
| Classification | Introducer, Catheter |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | De Graad |
| Correspondent | De Graad OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-03-10 |