The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Nitinol Catheter Guide Wire (145 Cm), Datascope Nitinol Catheter Guide Wire (175 Cm), Datascope Nitinol Cathet.
| Device ID | K001198 |
| 510k Number | K001198 |
| Device Name: | DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET |
| Classification | Wire, Guide, Catheter |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Wolf |
| Correspondent | Joann Wolf DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-13 |
| Decision Date | 2000-05-12 |