FDA.reportPublic FDA data

Finesse BTK Multicath

Primary DI
00810017490257
Brand
Finesse BTK Multicath
Company
Summa Therapeutics, LLC
Model
FS200201002
Device description
PTA CATH 2.0-020-100
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

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
00810017490257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017490257008100174902578100174902570810017490257

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 Length20Millimeter
Catheter Working Length100Centimeter

Sterilization Methods#

Method table
Method

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
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
00810017490455Finesse BTK MulticathFS2022510022025-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450826560Fountain®Merit Medical Systems, Inc.KRA2026-06-09
00191506067342TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067359TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067366TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067373TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyKRA2026-05-30
00885403523819VAMPBecton, Dickinson And CompanyKRA2026-05-30
00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023955Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
00763000539351RebarMicro Therapeutics, Inc.KRA2022-02-27