Günther Tulip® Vena Cava Filter Retrieval Set

Device, Percutaneous Retrieval

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Günther Tulip® Vena Cava Filter Retrieval Set.

Pre-market Notification Details

• Device ID: K181757
• 510k Number: K181757
• Device Name: Günther Tulip® Vena Cava Filter Retrieval Set
• Classification: Device, Percutaneous Retrieval
• Applicant: Cook Incorporated 750 Daniels Way; P.O. Box 489 Bloomington, IN 47402
• Contact: Steven Lawrie
• Correspondent: Jennifer Brown; Cook Research Incorporated 1 Geddes Way West Lafayette, IN 47906
• Product Code: MMX
• CFR Regulation Number: 870.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-02
• Decision Date: 2018-11-06
• Summary: summary