ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE

Laparoscope, General & Plastic Surgery

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Advance Salivary Balloon Catheter With Wire Guide.

Pre-market Notification Details

• Device ID: K140593
• 510k Number: K140593
• Device Name: ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404
• Contact: Larry D Pool
• Correspondent: Larry D Pool; COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-07
• Decision Date: 2014-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850007350420	K140593	000
00850007350413	K140593	000
00850007350406	K140593	000
00850007350390	K140593	000