510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Contego Medical, Inc

Raleigh, NC, US

CONTEGO MEDICAL, INC appears in FDA device records in Raleigh, NC. FDA records list 7 510(k) clearances between and , 9 PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
9
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Contego Medical, Inc between 2018 and 2025. The busiest year on record is 2018, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Contego Medical, Inc, by decision year
YearClearances
20182
20222
20232
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251485Excipio LV Prime Thrombectomy DeviceQEWSubstantially Equivalent
K230030Excipio SV Aspiration Catheter and TubingQEWSubstantially Equivalent
K223897Excipio LV Thrombectomy DeviceQEWSubstantially Equivalent
K221204Excipio SV Thrombectomy DeviceQEWSubstantially Equivalent
K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionLITSubstantially Equivalent
K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionLITSubstantially Equivalent
K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)LITSubstantially Equivalent

Registered establishments

FDA registered establishments for Contego Medical, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30114710563011471056CONTEGO MEDICAL, INC3801 Lake Boone Trail, Suite 100, Raleigh, NC 27607 US2026
30254659183025465918CONTEGO MEDICAL, INC2334D WALSH AVE, Santa Clara, CA 95051 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2911-2026Neuroguard 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-NV-7-30, NG-NV-7-40Carotid 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.Class IIOpen, Classified
Z-0131-2026Neuroguard 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-6-40Carotid 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.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain