FDA.reportPublic FDA data

HARBOR

Primary DI
00850072397528
Brand
HARBOR
Company
Nuvascular, Inc.
Model
04-OCCLUDE-040
Catalog number
04-OCCLUDE-040
Device description
HARBOR Occlusion Device
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250133000HARBOR Occlusion DeviceNuvascular, Inc.2025-07-09KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850072397528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850072397528008500723975288500723975280850072397528

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-688-2728customerservice@nuvascular.com

Regulatory Flags#

DUNS number
119270166
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072397481HARBOR04-OCCLUDE-02004-OCCLUDE-0202025-07-30
00850072397498HARBOR04-OCCLUDE-02504-OCCLUDE-0252025-07-30
00850072397504HARBOR04-OCCLUDE-03004-OCCLUDE-0302025-07-30
00850072397511HARBOR04-OCCLUDE-03504-OCCLUDE-0352025-07-30
00850072397535HARBOR04-OCCLUDE-04504-OCCLUDE-0452025-07-30
00850072397542HARBOR04-OCCLUDE-05004-OCCLUDE-0502025-07-30
00850072397559HARBOR04-OCCLUDE-05504-OCCLUDE-0552025-07-30
00850072397566HARBOR04-OCCLUDE-06004-OCCLUDE-0602025-07-30
00850072397573HARBOR04-OCCLUDE-06504-OCCLUDE-0652025-07-30
00850072397580HARBOR04-OCCLUDE-07004-OCCLUDE-0702025-07-30
00850072397597HARBOR04-OCCLUDE-08004-OCCLUDE-0802025-07-30
00850072397603HARBOR04-OCCLUDE-09004-OCCLUDE-0902025-07-30
00850072397610HARBOR04-OCCLUDE-10004-OCCLUDE-1002025-07-30
00850072397627HARBOR04-OCCLUDE-11004-OCCLUDE-1102025-07-30
00850072397634HARBOR04-OCCLUDE-12004-OCCLUDE-1202025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857798005093Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005109Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005123Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10841156105655GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105662GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105679GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
10841156106591GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106614GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106621GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106638GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
07613327466386TARGETStryker CorporationKRD2019-09-05
07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
10841156100001OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100018OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100025OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100032OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27