The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Arterial Cannula W/access Port.
Device ID | K902674 |
510k Number | K902674 |
Device Name: | DATASCOPE ARTERIAL CANNULA W/ACCESS PORT |
Classification | Cannula, Catheter |
Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
Contact | Robert B Schock,phd |
Correspondent | Robert B Schock,phd DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
Product Code | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-18 |
Decision Date | 1991-01-16 |