FDA.reportPublic FDA data

Reinforced Introducer Set for Sensation Plus & Mega 8Fr

Primary DI
10607567107943
Brand
Reinforced Introducer Set for Sensation Plus & Mega 8Fr
Company
DATASCOPE CORP.
Model
0684-00-0403-10
Catalog number
0684-00-0403-10
Device description
Reinforced Introducer Set for Sensation Plus & Mega 8Fr
Published
2023-03-14
Public version status
Update
Distribution status
Not 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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002365000DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SETDatascope Corp.2000-08-25DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567107943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756710794310607567107943

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
888-627-8383customer.support@maquet.com

Regulatory Flags#

DUNS number
001660786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr0684-00-0403-050684-00-0403-052023-03-14
10607567106694Reinforced Introducer Set for Sensation 7Fr0684-00-0403-060684-00-0403-062023-03-14
10607567510996TigerPaw Pro Left Atrial Appendage Closure Device35mm7500010992020-11-18
10607567107301MEGA 8Fr. 50cc IAB0684-00-0498-010684-00-0498-012016-09-15
10607567107318MEGA 8Fr. 50cc IAB (with APA)0684-00-0498-020684-00-0498-022016-09-15
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23
10607567107516Catheter Extenders for 50cc IAB’s 0684-00-05260684-00-05262016-09-14
10607567108001MEGA 8Fr. 50cc IAB (with Statlock)0684-00-0296-010684-00-0296-012016-09-15
10607567108018MEGA 8Fr. 50cc IAB (with Statlock & APA)0684-00-0296-020684-00-0296-022016-09-15
10607567108063SENSATION PLUS 7.5Fr. 40cc IAB & Accessories0684-00-0568-010684-00-0568-012016-09-15
10607567108605SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)0684-00-0576-010684-00-0576-012016-09-15
10607567109381Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S0684-00-0576-050684-00-0576-052016-09-15
10607567109411MEGA 8Fr. 50cc IAB (W/O Statlock)0684-00-0296-030684-00-0296-032016-09-15
10607567109428Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock)0684-00-0568-030684-00-0568-032016-09-15
10607567109435Sensation Plus 8Fr. 50cc IAB (W/O Statlock)0684-00-0576-030684-00-0576-032016-09-15
10607567109442Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China)0684-00-0568-050684-00-0568-052016-09-15
10607567109565Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only0684-00-0568-01U0684-00-0568-01U2016-09-15
10607567109619MEGA 8Fr. 50cc IAB with Accessories, US Only0684-00-0296-01U0684-00-0296-01U2016-09-16
10607567109626MEGA 8Fr. 50cc IAB with Accessories (APA), US Only0684-00-0296-02U0684-00-0296-02U2016-09-16
10607567109633Sensation Plus 8Fr. 50cc IAB with Accessories, US Only0684-00-0576-01U0684-00-0576-01U2016-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450438777Prelude® Short SheathMerit Medical Systems, Inc.DYB2026-10-23
10884450439392Prelude IDeal™Merit Medical Systems, Inc.DYB2026-10-21
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
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00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
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00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
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00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
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00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02