FDA.reportPublic FDA data

Recana Introducer Sheath, 16Fr x 30cm

Primary DI
00860008103864
Brand
Recana Introducer Sheath, 16Fr x 30cm
Company
Intervene, Inc.
Model
FG019
Published
2026-03-02
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

Related Records

Contact Domains

Product Codes

CodeName
KRACatheter, Continuous Flush

Product Code Classifications

CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions

SubmissionSupplement
K251185000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860008103864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008103864008600081038648600081038640860008103864

GMDN Terms

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

Contacts

PhoneEmail
6509957137customerservice@intervene-med.com

Regulatory Flags

DUNS number
056000927
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 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
00860008103857Recana Introducer Sheath, 13Fr x 90cmFG0182026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmFG0202026-03-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450826178Fountain®Merit Medical Systems, Inc.KRA2026-03-21
10884450470418Fountain®Merit Medical Systems, Inc.KRA2026-03-19
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-03-13
00860008103819Recana Debulking CatheterIntervene, Inc.KRA2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.KRA2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.KRA2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.KRA2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.KRA2026-03-02
10884450826352Fountain®Merit Medical Systems, Inc.KRA2026-02-21
10884450826222Fountain®Merit Medical Systems, Inc.KRA2026-02-18
10884450826543Fountain®Merit Medical Systems, Inc.KRA2026-02-14
10884450826635Fountain®Merit Medical Systems, Inc.KRA2026-02-14
G544ADM18130Agile AnglerAgile Devices, Inc.KRA2026-01-30
G544ADM18147Agile AnglerAgile Devices, Inc.KRA2026-01-30
10884450826185Fountain®Merit Medical Systems, Inc.KRA2026-01-29
10884450826208Fountain®Merit Medical Systems, Inc.KRA2026-01-16
00884450742921Merit Maestro®Merit Medical Systems, Inc.KRA2026-01-03
10884450826512Fountain®Merit Medical Systems, Inc.KRA2025-11-12
00857136004316TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00857136004323TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00884450742914Merit Maestro®Merit Medical Systems, Inc.KRA2025-09-19
10884450826420Fountain®Merit Medical Systems, Inc.KRA2025-08-06
10884450826482Fountain®Merit Medical Systems, Inc.KRA2025-06-03
10884450825997Fountain®Merit Medical Systems, Inc.KRA2025-05-16
10884450825546Fountain®Merit Medical Systems, Inc.KRA2025-05-13
10884450826413Fountain®Merit Medical Systems, Inc.KRA2025-05-13
00842429106228PG PROMICROVENTION INC.KRA2025-04-30
00842429118733VIA MicrocatheterMICROVENTION INC.KRA2025-04-30
00842429118740VIA MicrocatheterMICROVENTION INC.KRA2025-04-30