FDA.reportPublic FDA data

Finesse BTK Multicath

Primary DI
00810017490387
Brand
Finesse BTK Multicath
Company
Summa Therapeutics, LLC
Model
FS350601002
Device description
PTA-3.5-60-100
Published
2025-03-22
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
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017490387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017490387008100174903878100174903870810017490387

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter3.5Millimeter
Balloon Length60Millimeter
Catheter Working Length100Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877 267 2685info@summatherapeutics.com

Regulatory Flags#

DUNS number
091414591
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810017490257Finesse BTK MulticathFS2002010022025-03-22
00810017490264Finesse BTK MulticathFS2502010022025-03-22
00810017490271Finesse BTK MulticathFS3002010022025-03-22
00810017490288Finesse BTK MulticathFS3502010022025-03-22
00810017490295Finesse BTK MulticathFS4002010022025-03-22
00810017490301Finesse BTK MulticathFS2004010022025-03-22
00810017490318Finesse BTK MulticathFS2504010022025-03-22
00810017490325Finesse BTK MulticathFS3004010022025-03-22
00810017490332Finesse BTK MulticathFS3504010022025-03-22
00810017490349Finesse BTK MulticathFS4004010022025-03-22
00810017490356Finesse BTK MulticathFS2006010022025-03-22
00810017490363Finesse BTK MulticathFS2506010022025-03-22
00810017490370Finesse BTK MulticathFS3006010022025-03-22
00810017490394Finesse BTK MulticathFS4006010022025-03-22
00810017490400Finesse BTK MulticathFS2010010022025-03-22
00810017490417Finesse BTK MulticathFS2510010022025-03-22
00810017490424Finesse BTK MulticathFS3010010022025-03-22
00810017490431Finesse BTK MulticathFS3510010022025-03-22
00810017490448Finesse BTK MulticathFS4010010022025-03-22
00810017490455Finesse BTK MulticathFS2022510022025-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
00812013030086Instylla Microcatheter 1.2INSTYLLA INC.KRA2021-09-07
00812013030093Instylla Microcatheter 1.2INSTYLLA INC.KRA2021-09-07
00812013030109Instylla Microcatheter 1.2INSTYLLA INC.KRA2021-09-07
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26