FDA.reportPublic FDA data

Esperance

Primary DI
06970908211171
Brand
Esperance
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
DAC6F131
Device description
6F Distal access catheter
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231056000Esperance Distal Access CatheterWallaby Medical2024-03-08QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970908211171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908211171069709082111716970908211171

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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544535295
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970908212079Paragon 8F Balloon Guide CatheteBG8F0852026-04-15
06970908212086Paragon 8F Balloon Guide CatheteBG8F0952026-04-15
06970908212093Paragon 8F Balloon Guide CatheteBG8F0852024-10-11
06970908212109Paragon 8F Balloon Guide CatheteBG8F0952024-10-11
06970908212734Avenir10HSW010082025-01-15
06970908212741Avenir10HSW010102025-01-15
06970908212758Avenir10HSW015102025-01-15
06970908212765Avenir10HSW015152025-01-15
06970908212772Avenir10HSW020122025-01-15
06970908212789Avenir10HSW020202025-01-15
06970908212796Avenir10CSW010082025-01-15
06970908212802Avenir10CSW010102025-01-15
06970908212819Avenir10CSW015102025-01-15
06970908212826Avenir10CSW015152025-01-15
06970908212833Avenir10CSW020122025-01-15
06970908212840Avenir10CSW020202025-01-15
06970908212857Avenir10CSW030202025-01-15
06970908212864Avenir10CSW030302025-01-15
06970908212871Avenir10CSW040302025-01-15
06970908212888Avenir10CSW040402025-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270360Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270384Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270520Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270544Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270704Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270711Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270766Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270773Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270223Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270230Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270247Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270308Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07