Data / Medical devices / United States / Contego Medical, Inc

Contego Medical, Inc: FDA-registered device maker in Raleigh, NC, United States, 6 510(k) clearances and 1 PMA approval

Name: Contego Medical, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Contego Medical, Inc is registered with the FDA (registration 3011471056) in Raleigh, NC, United States. It lists 4 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated June 13, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011471056
Address: 3801 Lake Boone Trail, Suite 100, Raleigh, NC, United States, 27607
Owner or operator: Contego Medical, INC (10050012)
Roles: Complaint file establishment, Specification developer
First device listed: September 7, 2018
Registered through: 2027
Brand names listed: Excipio Aspiration Catheter and Tubing, Excipio LV Prime Thrombectomy Device, Excipio LV Thrombectomy Device, Excipio SV Thrombectomy Device, Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection, Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stent, Carotid	NIM	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Temporary Carotid Catheter For Embolic Capture	NTE	2	Complaint file establishment, Specification developer	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
June 13, 2025	K251485	Excipio LV Prime Thrombectomy Device	QEW	Substantially Equivalent	Contego Medical, Inc.	accessdata.fda.gov
May 30, 2023	K230030	Excipio SV Aspiration Catheter and Tubing	QEW	Substantially Equivalent	Contego Medical, Inc.	accessdata.fda.gov
February 17, 2023	K223897	Excipio LV Thrombectomy Device	QEW	Substantially Equivalent	Contego Medical, Inc.	accessdata.fda.gov
June 23, 2022	K221204	Excipio SV Thrombectomy Device	QEW	Substantially Equivalent	Contego Medical, Inc.	accessdata.fda.gov
June 9, 2022	K221339	Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection	LIT	Substantially Equivalent	Contego Medical, Inc.	accessdata.fda.gov
September 6, 2018	K181128	Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)	LIT	Substantially Equivalent	Contego Medical, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 11, 2024	P240009	Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection	NIM	8	July 29, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 29, 2026	99353	Class II	Ongoing	Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG	Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.	accessdata.fda.gov
September 4, 2025	97522	Class II	Ongoing	Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40	Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.	accessdata.fda.gov

Compare with other makers

Updated August 6, 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.