FDA.report

Recana Collection Basket, 30mm

Primary DI
00860008103833
Brand
Recana Collection Basket, 30mm
Company
Intervene, Inc.
Model
FG016
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
00860008103833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008103833008600081038338600081038330860008103833

GMDN Terms

TermDefinition
Thrombectomy wire-netA device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. 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
00860008103840Recana Introducer Sheath, 13Fr x 30cmFG0172026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmFG0182026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmFG0192026-03-02
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
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.KRA2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, 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