FDA.reportPublic FDA data

swiftMATCH Coil, Extra Soft

Primary DI
00810169722091
Brand
swiftMATCH Coil, Extra Soft
Company
PENUMBRA, INC.
Model
400SWXSFT206-A
Catalog number
400SWXSFT206
Device description
swiftMATCH Coil, Extra Soft, 2mm x 6cm
Published
2026-01-26
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
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230284000Penumbra LP Coil SystemPenumbra, Inc.2023-10-25HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810169722091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810169722091008101697220918101697220910810169722091

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-272-4606info@penumbrainc.com

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169720042ELEMENT Vascular Access SystemELMNT17F13-A2024-12-16
00810169720059ELEMENT Vascular Access SystemELMNT17F33-A2024-12-16
00810169720066ELEMENT Vascular Access SystemELMNT17F45-A2024-12-16
00810169720073ELEMENT Vascular Access SystemELMNT17F65-A2024-12-16
00810169720080ELEMENT Vascular Access SystemELMNT17F70-A2024-12-16
00810169720097ELEMENT Vascular Access SystemELMNT17F80-A2024-12-16
00815948028029MIDWAY43MWAY115-A2024-04-02
00815948028036MIDWAY62MWAY125-A2024-04-02
00815948028180MIDWAY43MWAY125-A2024-04-02
00815948028197MIDWAY62MWAY115-A2024-04-02
00815948026216Benchmark MAX SystemBMX96100SIM125-B2023-06-27
00815948026223Benchmark MAX SystemBMX96100MSIM125-B2023-06-27
00815948026230Benchmark MAX SystemBMX96100H1125-B2023-06-27
00815948026247Benchmark MAX SystemBMX96100MH1125-B2023-06-27
00815948026254Benchmark MAX SystemBMX96100BER125-B2023-06-27
00815948026261Benchmark MAX SystemBMX96100MBER125-B2023-06-27
00815948026278Benchmark MAX SystemBMX96100SIMV125-B2023-06-27
00815948026285Benchmark MAX SystemBMX96100MSIMV125-B2023-06-27
00815948026292Benchmark MAX SystemBMX96100-B2023-06-27
00815948026308Benchmark MAX SystemBMX9690SIM125-B2023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04546540689306GDC-10Stryker CorporationHCG2015-09-21