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
00840479402178enableCV QuickDraw™ Plus Venous CannulaQDP222026-08-27
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII016A2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII020A2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII018A2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII016AS2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII018AS2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaFEMII020AS2026-07-27
00840479401416enableCV EZ Glide Aortic CannulaEZF21A2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaEZF24A2026-07-09
00840479402222enableCV Percutaneous Insertion Kit-ArterialPIKA2026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27