OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER

Filter, Intravascular, Cardiovascular

CORDIS, A JOHNSON & JOHNSON CO.

The following data is part of a premarket notification filed by Cordis, A Johnson & Johnson Co. with the FDA for Optease Vena Cava Filter And Optease Retrieval Cathteter.

Pre-market Notification Details

• Device ID: K140286
• 510k Number: K140286
• Device Name: OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
• Classification: Filter, Intravascular, Cardiovascular
• Applicant: CORDIS, A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PARKWAY Fremont, CA 94555
• Contact: Shamsa Karimi
• Correspondent: Shamsa Karimi; CORDIS, A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PARKWAY Fremont, CA 94555
• Product Code: DTK
• CFR Regulation Number: 870.3375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-05
• Decision Date: 2014-03-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20705032072899	K140286	000
20705032072882	K140286	000
20705032072875	K140286	000
20705032009376	K140286	000
20705032009369	K140286	000