FDA.reportPublic FDA data

Valved Introducer

Primary DI
M991IK522212
Brand
Valved Introducer
Company
NORFOLK MEDICAL
Model
Flowguard
Catalog number
IK52221
Device description
8F Valved Introducer Kit
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M991IK522212PackageHIBCC2In Commercial Distribution
M991IK522211PrimaryHIBCC0

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
Length15Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(847)674-7075npheil@norfolkmedical.com

Regulatory Flags#

DUNS number
013861471
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M991IK312211Standard IntroducerStraight Wing TearawayIK312212015-09-01
M991IK512211Standard IntroducerStraight Wing TearawayIK512212015-09-01
M991IK522211Valved IntroducerFlowguardIK522212015-09-01
M991IK712211Standard IntroducerStraight Wing TearawayIK712212015-09-01
M991IK722211Valved IntroducerFlowguardIK722212015-09-01
M991IK812211Standard IntroducerStraight Wing TearawayIK812212015-09-01
M991CVS611101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS611102021-11-18
M991CVS612101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS612102021-11-18
M991CVS615101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS615102021-11-18
M991CVS622101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622102021-11-18
M991CVS611102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS611102021-11-18
M991CVS612102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS612102021-11-18
M991CVS615102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS615102021-11-18
M991CVS622301Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622302021-11-04
M991SCIG331361Clear-View Multi-site Subcutaneous Infusion SetClearView™MSSCIG331362020-10-19
M991TH011001Tidal High-Flow Non-coring NeedleTidal-HFTH011002015-10-06
M991TH012001Tidal High-Flow Non-coring NeedleTidal-HFTH012002015-10-06
M991TH013001Tidal High-Flow Non-coring NeedleTidal-HFTH013002015-10-06
M991TH021001Tidal High-Flow Non-coring NeedleTidal-HFTH021002015-10-06
M991TH022001Tidal High-Flow Non-coring NeedleTidal-HFTH022002015-10-06

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Primary DI, Brand, Company table
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10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
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10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
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