Caterpillar

Primary DI
00801741155307
Brand
Caterpillar
Company
CLEARSTREAM TECHNOLOGIES LIMITED
Model
CTP027015U
Catalog number
CTP027015U
Device description
Caterpillar Micro Arterial Embolization Device, 0.027 Inch ID Catheter Compatibility
Published
2020-02-10
Public version status
Update
Distribution status
Not 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
K191532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191532000The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.2020-02-04KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741155307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741155307008017411553078017411553070801741155307

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA sterile, 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(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
989214291
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
00801741184802Halo One™ Thin-Walled Guiding SheathHLO41018FHHLO41018FH2020-04-27
00801741184819Halo One™ Thin-Walled Guiding SheathHLO41035FHHLO41035FH2020-04-27
00801741184833Halo One™ Thin-Walled Guiding SheathHLO51018FHHLO51018FH2020-04-27
00801741184840Halo One™ Thin-Walled Guiding SheathHLO51035FHHLO51035FH2020-04-27
00801741184864Halo One™ Thin-Walled Guiding SheathHLO61035FHHLO61035FH2020-04-27
00801741223778Halo One Thin-Walled Guiding SheathHLO41018FHKHLO41018FHK2021-12-14
00801741223785Halo One Thin-Walled Guiding SheathHLO41035FHKHLO41035FHK2021-12-14
00801741223815Halo One Thin-Walled Guiding SheathHLO51018FHKHLO51018FHK2021-12-14
00801741223822Halo One Thin-Walled Guiding SheathHLO51035FHKHLO51035FHK2021-12-14
00801741223853Halo One Thin-Walled Guiding SheathHLO61035FHKHLO61035FHK2021-12-14
00801741223907Halo One Thin-Walled Guiding SheathHLO61018FHKHLO61018FHK2021-12-14
00801741184826Halo One™ Thin-Walled Guiding SheathHLO42535HHLO42535H2020-04-27
00801741184857Halo One™ Thin-Walled Guiding SheathHLO52535HHLO52535H2020-04-27
00801741184871Halo One™ Thin-Walled Guiding SheathHLO62535HHLO62535H2020-04-27
00801741223792Halo One Thin-Walled Guiding SheathHLO42518HKHLO42518HK2021-12-14
00801741223808Halo One Thin-Walled Guiding SheathHLO42535HKHLO42535HK2021-12-14
00801741223839Halo One Thin-Walled Guiding SheathHLO52518HKHLO52518HK2021-12-14
00801741223846Halo One Thin-Walled Guiding SheathHLO52535HKHLO52535HK2021-12-14
00801741223860Halo One Thin-Walled Guiding SheathHLO62535HKHLO62535HK2021-12-14
00801741223914Halo One Thin-Walled Guiding SheathHLO62518HKHLO62518HK2021-12-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10886704080152GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
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10886704077374DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704076933DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076940DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077091DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077114DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077121DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077138DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077145DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077152DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077169DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077190DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077213MICRUSFRAMECerenovus, Inc.KRD2016-11-16
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10886704077237DELTAFILLCerenovus, Inc.KRD2016-11-16