The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Slidewire(tm).
| Device ID | K901347 |
| 510k Number | K901347 |
| Device Name: | DATASCOPE SLIDEWIRE(TM) |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-23 |
| Decision Date | 1990-06-21 |