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Penumbra Costa Rica, S.R.L.: FDA-registered device maker in Guadalupe Cartago, Costa Rica, 12 510(k) clearances

Name: Penumbra Costa Rica, S.R.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Penumbra Costa Rica, S.R.L. is registered with the FDA (registration 3043869342) in Guadalupe Cartago, Costa Rica. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 15, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3043869342
Address: Zona Franca La Lima, Multitenant dos Suites siete y ocho, Guadalupe Cartago, Costa Rica, 30106
Owner or operator: PENUMBRA, INC. (9072336)
Roles: Manufacturer
First device listed: November 15, 2011
Registered through: 2027
Brand names listed: INDIGO Aspiration System, PC 400, POD Packing Coil, POD System, Penumbra Coil System, Penumbra LP Coil System, Penumbra PC400 Embolization Coil, Penumbra POD Embolization Coil and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Neurovascular Embolization	HCG	2	Manufacturer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 15, 2026	K262904	INDIGO® Aspiration System	QEW	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
March 14, 2025	K250079	Ruby XL System	KRD	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
October 25, 2023	K230284	Penumbra LP Coil System	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
November 20, 2019	K192955	Penumbra LP Coil System	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
April 17, 2018	K173614	Penumbra Coil 400, Ruby Coil System, POD System	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
July 19, 2017	K170852	POD Packing Coil	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
April 20, 2016	K160832	Penumbra Smart Coil	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
July 10, 2015	K151572	Penumbra Smart Coil	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
March 18, 2015	K143218	Penumbra Smart Coil	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
July 3, 2014	K141134	POD SYSTEM	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
April 2, 2012	K120330	PENUMBRA COIL SYSTEM/PENUMBRA COIL 400	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
January 26, 2011	K103305	PENUMBRA EMBOLIZATION COIL SYSTEM	HCG	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.