FDA.reportPublic FDA data

Nanoparasol, Peel Away

Primary DI
00842429117231
Brand
Nanoparasol, Peel Away
Company
Microvention, Inc.
Model
PNP6514C-190-01
Catalog number
PNP6514C-190
Device description
Nanoparasol, Peel Away
Published
2025-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTETemporary Carotid Catheter for Embolic Capture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTETemporary Carotid Catheter For Embolic CaptureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222694000EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.2023-04-27NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429117231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429117231008424291172318424291172310842429117231

GMDN Terms#

Term, Definition table
TermDefinition
Carotid artery embolic protection systemAn assembly of devices intended to provide cerebrovascular embolic protection during carotid artery angioplasty and stenting procedures. It is available in various configurations and typically includes a sheath/catheter(s), intravascular balloon(s), guidewire, and extracorporeal valves/filters. The assembly is introduced into an artery percutaneously and used to produce blockage of blood through balloon inflation, typically at the carotid bifurcation and internal carotid artery to prevent distal embolization by particulate debris/thrombus and allow removal of debris/thrombus by blood filtration or aspiration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714) 247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429117224Nanoparasol, Peel AwayMicrovention, Inc.NTE2025-08-01
00851616007149Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007156Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007293PaladinContego Medical, Inc.NTE2023-09-05
00851616007385Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007453Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007460Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007477PaladinContego Medical, Inc.NTE2023-09-05
00851616007538Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007002PaladinContego Medical, Inc.NTE2023-09-05
00851616007309PaladinContego Medical, Inc.NTE2023-09-05
00811311021062ENROUTE Transcarotid Neuroprotection SystemBOSTON SCIENTIFIC CORPORATIONNTE2023-04-24
10705032053501ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032053556ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032054805ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032055819ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056748ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056793ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056830ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056854ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056892ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056939ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056946ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053508ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053553ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032054802ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032055816ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056745ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056790ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056837ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11