The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Guide Wire.
Device ID | K870664 |
510k Number | K870664 |
Device Name: | GUIDE WIRE |
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 | 1987-02-19 |
Decision Date | 1987-03-25 |