IntraSight

Cable, Transducer And Electrode, Patient, (including Connector)

Volcano Corporation

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Intrasight.

Pre-market Notification Details

• Device ID: K190078
• 510k Number: K190078
• Device Name: IntraSight
• Classification: Cable, Transducer And Electrode, Patient, (including Connector)
• Applicant: Volcano Corporation 3721 Valley Ctrre Dr Ste 500 San Diego, CA 92130
• Contact: Kimberly Simon
• Correspondent: Kimberly Simon; Volcano Corporation 3721 Valley Ctrre Dr Ste 500 San Diego, CA 92130
• Product Code: DSA
• Subsequent Product Code: DSK
• Subsequent Product Code: IYO
• CFR Regulation Number: 870.2900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-16
• Decision Date: 2019-02-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845225012878	K190078	000
00845225012847	K190078	000
00845225012922	K190078	000