FDA.reportPublic FDA data

Progreat Lambda

Primary DI
04987350740984
Brand
Progreat Lambda
Company
TERUMO CLINICAL SUPPLY CO., LTD.
Model
CC*M1916SN
Catalog number
CCM1916SN
Device description
Micro Catheter System
Published
2022-04-07
Public version status
New
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
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211078000Progreat LambdaTerumo Clinical Supply Co., Ltd.2021-12-21DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350740989PackageGS15In Commercial Distribution
04987350740984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735074098954987350740989
04987350740984049873507409844987350740984

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.48Millimeter
Length165Centimeter
Outer Diameter0.64Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
691034748
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350737267Progreat LambdaCC-MC913SNCCM1913SN2025-05-20
04987350737304Progreat LambdaCC-MC913DNCCM1913DN2025-05-20
04987350737328Progreat LambdaCC-MC915SNCCM1915SN2025-05-20
04987350737342Progreat LambdaCC-MC915ANCCM1915AN2025-05-20
04987350737366Progreat LambdaCC-MC915DNCCM1915DN2025-05-20
54987350737262Progreat LambdaCC-MC913SNCCM1913SN2025-05-20
04987350737281Progreat LambdaCC-MC913ANCCM1913AN2025-05-20
54987350737309Progreat LambdaCC-MC913DNCCM1913DN2025-05-20
54987350737323Progreat LambdaCC-MC915SNCCM1915SN2025-05-20
54987350737347Progreat LambdaCC-MC915ANCCM1915AN2025-05-20
54987350737361Progreat LambdaCC-MC915DNCCM1915DN2025-05-20
04543334177254PRIORITYONEUG160230-61002016-09-16
04543334177261PRIORITYONEUG165230-71002016-09-16
04987350741004Progreat LambdaCC*M1916ANCCM1916AN2022-04-07
04987350741028Progreat LambdaCC*M1916DNCCM1916DN2022-04-07
54987350741009Progreat LambdaCC*M1916ANCCM1916AN2022-04-07
54987350741023Progreat LambdaCC*M1916DNCCM1916DN2022-04-07
54543334177259PRIORITYONE30-6100UG16022016-09-16
74543334177260PRIORITYONE30-7100UG16522016-09-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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