FDA.report

Finesse Injectable PTA Balloon Dilatation Catheter OTW 014

Primary DI
00810017490226
Brand
Finesse Injectable PTA Balloon Dilatation Catheter OTW 014
Company
Summa Therapeutics, LLC
Model
FS302251508
Device description
PTA CATH 3.0-225-150-8
Published
2023-08-01
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
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions

SubmissionSupplement
K230263000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230263000FinesseĀ™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC2023-05-26LIT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810017490226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017490226008100174902268100174902260810017490226

GMDN Terms

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

TypeValueUnit
Balloon Diameter3Millimeter
Balloon Length225Millimeter
Catheter Working Length150Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
800 615-4937help@summatherapeutics.com

Regulatory Flags

DUNS number
091414591
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
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

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