GUIDEWIRE

Wire, Guide, Catheter

DATASCOPE CORP.

The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Guidewire.

Pre-market Notification Details

• Device ID: K904477
• 510k Number: K904477
• Device Name: GUIDEWIRE
• Classification: Wire, Guide, Catheter
• Applicant: DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436
• Contact: Roberet B Schock
• Correspondent: Roberet B Schock; 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: 1990-10-01
• Decision Date: 1990-12-06