FDA.report

510(k) K211654

Device
Penumbra System (Reperfusion Catheter RED 72)
Applicant
Penumbra, Inc.
510(k) number
K211654
Product code
NRY
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-16
Date received
2021-05-28
Regulation
870.1250
Classification name
Catheter, Thrombus Retriever
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nikita Patel
Address
One Penumbra Pl. Alameda CA US 95132 95132

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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