FDA.reportPublic FDA data

enableCV Introducer Sheath

Primary DI
00840479401263
Brand
enableCV Introducer Sheath
Company
ENABLECV INC.
Model
IS19A
Device description
Introducer Sheath - IS19A
Published
2026-02-26
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972570000HEARTPORT INTRODUCER SHEATHHeartport, Inc.1997-10-01DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840479401263PackageGS11In Commercial Distribution
00840479401256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479401263008404794012638404794012630840479401263
00840479401256008404794012568404794012560840479401256

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store sterile packaged device in a cool dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(888)943-2783customerservice@enablecv.com

Regulatory Flags#

DUNS number
119247843
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
true
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
00840479400228enableCV Dual Stage Venous Drainage CannulaTR3651B2026-04-30
00840479400402enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3343OA2026-04-30
00840479401270enableCV Retrograde Cardioplegia CatheterRC014M2026-04-30
00840479401294enableCV Retrograde Cardioplegia CatheterRC092026-04-30
00840479401317enableCV Retrograde Cardioplegia CatheterRC09M2026-04-30
00840479401331enableCV Retrograde Cardioplegia CatheterRC2012M2026-04-30
00840479401355enableCV Retrograde Cardioplegia CatheterRC2014LB2026-04-30
00840479401379enableCV Retrograde Cardioplegia CatheterRC2014M2026-04-30
00840479401478enableCV AViD Dual Stage Venous Drainage CannulaTF2929012026-04-30
00840479401515enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF2937O2026-04-30
00840479401553enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3646O1202026-04-30
00840479400594enableCV Thin-Flex Single Stage Venous Drainage CannulaTF034L2026-04-27
00840479401577enableCV ThinFlex Single Stage Venous Drainage CannulaTF012L2026-04-27
00840479401591enableCV ThinFlex Single Stage Venous Drainage CannulaTF014L2026-04-27
00840479401614 enableCV ThinFlex Single Stage Venous Drainage CannulaTF018L2026-04-27
00840479401638enableCV ThinFlex Single Stage Venous Drainage CannulaTF018O902026-04-27
00840479401652enableCV ThinFlex Single Stage Venous Drainage CannulaTF020L2026-04-27
00840479401676enableCV ThinFlex Single Stage Venous Drainage CannulaTF022L2026-04-27
00840479401690enableCV ThinFlex Single Stage Venous Drainage CannulaTF024L2026-04-27
00840479401973enableCV ThinFlex Single Stage Venous Drainage CannulaTF016L2026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
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