FDA.reportPublic FDA data

Smart Coil

Primary DI
00814548017341
Brand
Smart Coil
Company
PENUMBRA, INC.
Model
400SMTHXSFT4H06
Device description
400SMTHXSFT4H06
Published
2016-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143218000Penumbra Smart CoilPenumbra, Inc.2015-03-18HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548017341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548017341008145480173418145480173410814548017341

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814548014258Smart Coil400SMTSTD13452016-07-30
00814548014265Smart Coil400SMTSTD13602016-07-30
00814548014272Smart Coil400SMTSTD14452016-07-30
00814548014289Smart Coil400SMTSTD14602016-07-30
00814548014296Smart Coil400SMTSTD15452016-07-30
00814548014302Smart Coil400SMTSTD15602016-07-30
00814548014319Smart Coil400SMTSTD16452016-07-30
00814548014326Smart Coil400SMTSTD16602016-07-30
00814548014333Smart Coil400SMTSTD18452016-07-30
00814548014340Smart Coil400SMTSTD18602016-07-30
00814548014357Smart Coil400SMTSTD09202016-07-30
00814548014364Smart Coil400SMTSTD09302016-07-30
00814548014395Smart Coil400SMTSTD10302016-07-30
00814548014401Smart Coil400SMTSTD10452016-07-30
00814548014418Smart Coil400SMTSTD11452016-07-30
00814548014425Smart Coil400SMTSTD11602016-07-30
00814548014432Smart Coil400SMTSTD12452016-07-30
00814548014449Smart Coil400SMTSTD12602016-07-30
00814548014463Smart Coil400SMTSTD11352016-07-30
00814548014470Smart Coil400SMTSTD12352016-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327635096InZone ISTStryker CorporationHCG2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
M242RBYPODJ150PODPENUMBRA, INC.HCG2024-08-15
M424RBYPODJ150PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ600PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ450PODPENUMBRA, INC.HCG2016-08-01
M4244002C03060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04080Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04120Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C06100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30