FDA.reportPublic FDA data

Penumbra Coil 400

Primary DI
00815948024953
Brand
Penumbra Coil 400
Company
PENUMBRA, INC.
Model
400PAC6
Catalog number
400PAC6
Device description
PAC400, 6 cm
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K173614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173614000Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.2018-04-17HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948024953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024953008159480249538159480249530815948024953

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

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
00810169723586swiftMATCH Coil, Extra Soft400SWXSFT510-A400SWXSFT5102026-10-01
00810169723593swiftMATCH Coil, Extra Soft400SWXSFT615-A400SWXSFT6152026-10-01
00810169723609swiftMATCH Coil, Soft400SWSFT610-A400SWSFT6102026-10-01
00810169723616swiftMATCH Coil, Soft400SWSFT615-A400SWSFT6152026-10-01
00810169723623swiftMATCH Coil, Soft400SWSFT715-A400SWSFT7152026-10-01
00810169723630swiftMATCH Coil, Soft400SWSFT820-A400SWSFT8202026-10-01
00810169723647swiftMATCH Coil, Standard400SWSTD408-A400SWSTD4082026-10-01
00810169723654swiftMATCH Coil, Standard400SWSTD510-A400SWSTD5102026-10-01
00810169723661swiftMATCH Coil, Standard400SWSTD515-A400SWSTD5152026-10-01
00810169723678swiftMATCH Coil, Standard400SWSTD615-A400SWSTD6152026-10-01
00810169723685swiftMATCH Coil, Standard400SWSTD620-A400SWSTD6202026-10-01
00810169723692swiftMATCH Coil, Standard400SWSTD725-A400SWSTD7252026-10-01
00810169723708swiftMATCH Coil, Standard400SWSTD830-A400SWSTD8302026-10-01
00810169724217Ruby XL Coil SystemRBYPODXL0310-ARBYPODXL03102026-10-01
00810169724224Ruby XL Coil SystemRBYPODXL0320-ARBYPODXL03202026-10-01
00810169724231Ruby XL Coil SystemRBYPODXL0720-ARBYPODXL07202026-10-01
00810169724248Ruby XL Coil SystemRBYPODXL0755-ARBYPODXL07552026-10-01
00810169724255Ruby XL Coil SystemRBYPODXL0830-ARBYPODXL08302026-10-01
00810169724262Ruby XL Coil SystemRBYPODXL0930-ARBYPODXL09302026-10-01
00810169724279Ruby XL Coil SystemRBYPODXL0955-ARBYPODXL0955-A2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01