FDA.reportPublic FDA data

All'InCath 035M PTA Balloon Dilatation Catheter

Primary DI
03701261100412
Brand
All'InCath 035M PTA Balloon Dilatation Catheter
Company
NEXSTEP MEDICAL
Model
1
Catalog number
AL035P-80-5x80
Device description
All'InCath 035M PTA Balloon Dilatation Catheter
Published
2024-10-01
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191275000All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical2020-01-15LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701261100412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701261100412037012611004123701261100412

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 Diameter5Millimeter
Balloon Length80Millimeter
Balloon Nominal (Inflation) Pr9Atmosphere
Balloon Rated Burst Pressure16Atmosphere
Catheter Length80Centimeter
Guidewire Compatibility0.035French
Introducer Sheath Compatibilit6French
Pressure1100Pound per Square Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999info@nexstepmedical.com

Regulatory Flags#

DUNS number
266039102
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701261100009All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-4x202025-06-12
03701261100023All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-10x202025-06-12
03701261100047All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-9x202025-06-12
03701261100054All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-8x802025-06-12
03701261100061All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-8x602025-06-12
03701261100085All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-8x202025-06-12
03701261100108All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-7x602025-06-12
03701261100122All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-7x202025-06-12
03701261100160All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-6x202025-06-12
03701261100207All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-5x202025-06-12
03701261100214All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-4x802025-06-12
03701261100221All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-4x602025-06-12
03701261100245All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-120-4x202025-06-12
03701261100269All'InCath 035M PTA Balloon Dilatation Catheter1ALP035-80-10x202025-06-12
03701261100283All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-9x202025-06-12
03701261100290All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-8x802025-06-12
03701261100306All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-8x602025-06-12
03701261100320All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-8x202025-06-12
03701261100344All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-7x602025-06-12
03701261100368All'InCath 035M PTA Balloon Dilatation Catheter1AL035P-80-7x202025-06-12

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