Cleared Special

K152840 - Lantern Delivery Microcatheter

K152840 is the FDA 510(k) clearance for Lantern Delivery Microcatheter by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 64-day FDA review.

K152840 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
64d
Days
Class 2
Risk

K152840 is an FDA 510(k) clearance for the Lantern Delivery Microcatheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on December 2, 2015 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K152840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date December 02, 2015
Days to Decision 64 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 468
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K152840.
ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016
ASAHI Caravel
K152447 · Asahi Intecc Co., Ltd. · Jan 2016
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667 · Stryker · Nov 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · Biotronik, Inc. · Aug 2015
ASAHI Corsair Microcatheter
K151103 · Asahi Intecc Co., Ltd. · Jun 2015