FDA.reportPublic FDA data

ProtekSolo

Primary DI
00814112020463
Brand
ProtekSolo
Company
CARDIACASSIST, INC.
Model
5100-1422
Device description
Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)
Published
2017-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162181000Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.2017-01-06DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020463008141120204638141120204630814112020463

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4129637770gjohnson@tandemlife.com
18003737421gjohnson@tandemlife.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814112020166PROTEK Duo5140-46292015-10-10
00814112020319ProtekDuo5140-51312016-09-23
00814112020067TandemHeart5140-62212015-10-10
00814112020098TandemHeart5140-62172015-10-10
00814112020104TandemHeart5130-17175130-17172015-10-10
00814112020111TandemHeart5130-17155130-17152015-10-10
00814112020449ProtekSolo5140-60245140-60242017-01-27
00814112020456ProtekDuo5100-14262017-05-22
00814112020623LifeSPARC5900-00012020-05-27
00814112020630LifeSPARC5900-00022020-05-27
00814112020692TandemLife LifeSPARC5840-24172020-06-01
00814112020906LifeSPARC5900-00125900-00122022-05-10
00814112020609LifeSPARC5800-10002020-05-29
00814112020685TandemLife LifeSPARC5840-00002020-05-29
00814112020753TandemLung LifeSPARC5830-29162020-05-29
00814112020760TandemLung LifeSPARC5830-31182020-05-29
00814112020777TandemLung LifeSPARC5830-36312020-05-29
00814112020814LifeSPARC5800-10012020-05-29
00814112020562LifeSPARC5900-00002019-12-18
00814112020579LifeSPARC5900-00032019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDRE2023-09-01