Penumbra System

Catheter, Thrombus Retriever

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System.

Pre-market Notification Details

• Device ID: K180008
• 510k Number: K180008
• Device Name: Penumbra System
• Classification: Catheter, Thrombus Retriever
• Applicant: Penumbra, Inc. One Penumbra Place Alameda, CA 94502
• Contact: Richard Kimura
• Correspondent: Michaela Mahl; Penumbra, Inc. One Penumbra Place Alameda, CA 94502
• Product Code: NRY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-02
• Decision Date: 2018-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814548010007	K180008	000
00815948020023	K180008	000
00814548019758	K180008	000
00815948020030	K180008	000