FDA.reportPublic FDA data

Syntrax Support Catheter

Primary DI
H787141350
Brand
Syntrax Support Catheter
Company
ANGIODYNAMICS, INC.
Model
14-135
Device description
"Syntrax Catheter, .014"" x 135cm Support Catheter, Packaged, Sterile"
Published
2021-11-02
Public version status
Update
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
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200317000Support CatheterQxmedical, LLC2020-05-14DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787141350PrimaryHIBCC0
15051684029490SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402949015051684029490

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Device Size Text, specify0
Length135Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787TDST0AngioDynamicsH787TDST0TDS-T2026-06-04
15051684023955Uni-Fuse+H787124018640124018642024-08-01
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
15051684023856Uni-Fuse+H787124018520124018522024-08-01
15051684023863Uni-Fuse+H787124018540124018542024-08-01
15051684023870Uni-Fuse+H787124018550124018552024-08-01
15051684023887Uni-Fuse+H787124018570124018572024-08-01
15051684023894Uni-Fuse+H787124018580124018582024-08-01
15051684023900Uni-Fuse+H787124018590124018592024-08-01
15051684023924Uni-Fuse+H787124018610124018612024-08-01
15051684023931Uni-Fuse+H787124018620124018622024-08-01
15051684023948Uni-Fuse+H787124018630124018632024-08-01
15051684030069NanoKnifeH78720300351US020300351US2026-05-04
15051684013727NanoKnifeH78720300301US020300301US2026-04-30
15051684017930NanoKnifeH787204001090204001092026-04-30
15051684017947NanoKnifeH787204001100204001102026-04-30
15051684017954NanoKnifeH787204003010204003012026-04-30

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Primary DI, Brand, Company table
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00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
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07613327623376AXS LiftStryker CorporationDQY2025-03-04
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