CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090

Set, Administration, Intravascular

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Checkvalve Administration Set, Model 21-7090.

Pre-market Notification Details

• Device ID: K000942
• 510k Number: K000942
• Device Name: CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
• Classification: Set, Administration, Intravascular
• Applicant: SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112
• Contact: Lisa Stone
• Correspondent: Lisa Stone; SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-23
• Decision Date: 2000-04-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30610586034507	K000942	000