FDA.reportPublic FDA data

EchelonTM

Primary DI
00847536006294
Brand
EchelonTM
Company
Micro Therapeutics, Inc.
Model
190-5091-150
Device description
190-5091-150 ECHELON10 90 PRESHAPE TIP
Published
2016-04-05
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
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042187000
K051990000
K093750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042187000ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90Micro Therapeutics, Inc.2004-09-02KRA
K051990000ECHELON MICRO CATHETERMicro Therapeutics, Inc.2006-01-04KRA
K093750000ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAEv3, Inc.2009-12-09KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536006294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536006294008475360062948475360062940847536006294

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000270179Solitaire™ X-PACKXPACK2012019-11-08
00763000270193Solitaire™ X-PACKXPACK2032019-11-08
00763000270353Solitaire™ X-PACKXPACK3012019-11-08
00763000270377Solitaire™ X-PACKXPACK3032019-11-08
00763000270537Solitaire™ X-PACKXPACK3192019-11-08
00763000270551Solitaire™ X-PACKXPACK3212019-11-08
00763000270216Solitaire™ X-PACKXPACK2052019-11-07
00763000270230Solitaire™ X-PACKXPACK2072019-11-07
00763000270254Solitaire™ X-PACKXPACK2092019-11-07
00763000270292Solitaire™ X-PACKXPACK2132019-11-07
00763000270315Solitaire™ X-PACKXPACK2152019-11-07
00763000270339Solitaire™ X-PACKXPACK2172019-11-07
00763000270391Solitaire™ X-PACKXPACK3052019-11-07
00763000270414Solitaire™ X-PACKXPACK3072019-11-07
00763000270438Solitaire™ X-PACKXPACK3092019-11-07
00763000270476Solitaire™ X-PACKXPACK3132019-11-07
00763000270490Solitaire™ X-PACKXPACK3152019-11-07
00763000270513Solitaire™ X-PACKXPACK3172019-11-07
00763000270582Solitaire™ X-PACKXPACK3242019-11-07
00763000270605Solitaire™ X-PACKXPACK3262019-11-07

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Primary DI, Brand, Company table
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