FDA.reportPublic FDA data

Zurpaz™ Steerable Sheath Set

Primary DI
05391526210031
Brand
Zurpaz™ Steerable Sheath Set
Company
CREGANNA UNLIMITED COMPANY
Model
M004EPTMC85300
Catalog number
M004EPTMC85300
Device description
Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131079000CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRICCreganna Medical Devices2013-08-01DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391526210031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391526210031053915262100315391526210031

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Regulatory Flags#

DUNS number
985218606
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391526210048Zurpaz™ Steerable Sheath SetM004EPTMCA85400M004EPTMCA854002016-09-23
05391526210055Zurpaz™ Steerable Sheath SetM004USMC85100M004USMC851002016-09-23
05391526210062Zurpaz™ Steerable Sheath SetM004USMCA85200M004USMCA852002016-09-23
05391526210079Zurpaz™ Steerable Sheath SetM004JPNMC85500M004JPNMC855002016-09-23
05391526210086Zurpaz™ Steerable Sheath SetM004JPNMCA85600M004JPNMCA856002016-09-23
05391526210253Attain Assist™ CS Access Catheter146168-01146168-012019-01-14
05391526210017Gore TIPS® SheathTSTH1040TSTH10402016-09-23
05391526210109Lotus™ Introducer SetH749NTR180LIS-S2016-09-23
05391526210116Lotus™ Introducer SetH749NTR200LIS-L2016-09-23
25391526210028Gore TIPS SetTSET1016TSET10162016-09-23
05391526210000Gore TIPS NeedleTNDL1656TNDL16562016-09-23
05391526210154Trapper™ Exchange DeviceH74939330130H749393301302017-01-27

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Primary DI, Brand, Company table
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