The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Guide Wire For The Use With Datascope Percor Stat-dl Iabs.
| Device ID | K943896 |
| 510k Number | K943896 |
| Device Name: | GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS |
| Classification | Wire, Guide, Catheter |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Diane M Arpino |
| Correspondent | Diane M Arpino DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-10 |
| Decision Date | 1995-12-22 |