FDA.reportPublic FDA data

Recana Introducer Sheath, 13Fr x 90cm

Primary DI
00860008103857
Brand
Recana Introducer Sheath, 13Fr x 90cm
Company
Intervene, Inc.
Model
FG018
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251185000Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)Intervene2025-10-22QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008103857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008103857008600081038578600081038570860008103857

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6509957137customerservice@intervene-med.com

Regulatory Flags#

DUNS number
056000927
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008103819Recana Debulking CatheterFG0142026-03-02
00860008103826Recana Collection Basket, 18mmFG0152026-03-02
00860008103833Recana Collection Basket, 30mmFG0162026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmFG0172026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmFG0192026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmFG0202026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
00884450825969Fountain®Merit Medical Systems, Inc.KRA2026-06-24
00884450826560Fountain®Merit Medical Systems, Inc.KRA2026-06-09
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.QEW2023-10-27
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.QEW2022-06-22
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399672PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399702PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399719PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26