FDA.reportPublic FDA data

Finesse BTK Multicath

Primary DI
00810017490455
Brand
Finesse BTK Multicath
Company
Summa Therapeutics, LLC
Model
FS202251002
Device description
PTA-2.0-225-100
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
00810017490455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017490455008100174904558100174904550810017490455

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 Diameter2Millimeter
Balloon Length225Millimeter
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
00810017490387Finesse BTK MulticathFS3506010022025-03-22
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

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
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
00763000399733PhenomTM Plus CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000270162Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08