Cleared Traditional

K090752 - PENUMBRA SYSTEM (PENNUMBRA REPERFUSION ...

Also marketed or referenced as:
(PENUMBRA SEPARATOR 054), MODEL PSS054

K090752 is the FDA 510(k) clearance for PENUMBRA SYSTEM (PENNUMBRA REPERFUSION ... by Penumbra, Inc.. It is a Class 2 Neurology device (product code NRY) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K090752 · Penumbra, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2009
Decision
185d
Days
Class 2
Risk

K090752 is an FDA 510(k) clearance for the PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on September 21, 2009 after a review of 185 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K090752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date September 21, 2009
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 148d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 100
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K090752.
PENUMBRA SYSTEM MAX
K113163 · Penumbra, Inc. · Nov 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K093610 · Concentric Medical, Inc. · Feb 2011
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
K100769 · Penumbra, Inc. · May 2010
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
K090085 · Concentric Medical, Inc. · Feb 2009
MODIFICATION TO MERCI RETRIEVER
K082034 · Concentric Medical, Inc. · Aug 2008
MERCI RETRIEVER
K081305 · Concentric Medical, Inc. · Jun 2008