CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH

Catheter, Percutaneous

FUJI SYSTEMS CORP.

The following data is part of a premarket notification filed by Fuji Systems Corp. with the FDA for Cello Balloon Guide Catheter (6f), 950 Mm And 1020 Mm Length.

Pre-market Notification Details

• Device ID: K120781
• 510k Number: K120781
• Device Name: CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
• Classification: Catheter, Percutaneous
• Applicant: FUJI SYSTEMS CORP. 3250 SECOND AVENUE San Diego, CA 92103
• Contact: Paul Mason
• Correspondent: Paul Mason; FUJI SYSTEMS CORP. 3250 SECOND AVENUE San Diego, CA 92103
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-15
• Decision Date: 2012-08-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04544050093491	K120781	000
04544050093484	K120781	000
04544050093460	K120781	000
04544050093446	K120781	000
14544050120743	K120781	000
14544050120736	K120781	000
04544050120722	K120781	000
04544050120715	K120781	000