SPINNAKER

Catheter, Continuous Flush

TARGET THERAPEUTICS

The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Spinnaker.

Pre-market Notification Details

• Device ID: K965189
• 510k Number: K965189
• Device Name: SPINNAKER
• Classification: Catheter, Continuous Flush
• Applicant: TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538
• Contact: Lloyd Griese
• Correspondent: Lloyd Griese; TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538
• Product Code: KRA
• CFR Regulation Number: 870.1210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-24
• Decision Date: 1997-03-24
• Summary: summary