The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Rotating Hemostatic Valve.
| Device ID | K890800 |
| 510k Number | K890800 |
| Device Name: | ROTATING HEMOSTATIC VALVE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Schneider, Phd |
| Correspondent | Schneider, Phd DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-16 |
| Decision Date | 1989-06-12 |