FDA.report

Soft-Vu

Primary DI
25051684009642
Company
Angiodynamics, Inc.
Model
H787107320010
Catalog number
10732001
Device description
Soft-Vu Angiographic Catheter, Sos Omni Selective (2), Non-Braided
Published
2025-02-27
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

Regulatory Flags

DUNS number
079252781
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
25051684009642PackageGS15In Commercial Distribution
H787107320010PreviousHIBCC0
15051684009645PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
25051684009642PackageGS15BX15051684009645In Commercial Distribution
H787107320010PreviousHIBCC0
15051684009645PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQOCatheter, Intravascular, Diagnostic2Cardiovascular870.1200NEligible

Premarket Submissions

SubmissionSupplement
K112452000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K112452000ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERSAngioDynamics, Inc.2012-03-30DQO

GMDN Terms

TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes

TypeValueText
Catheter Gauge5 French
Length80 Centimeter
Outer Diameter1.71 Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
25051684011713AngioDynamicsH787065200010065200012025-11-14
25051684029985BioFloH96546032046-0322025-03-18
25051684029992BioFloH96546033046-0332025-03-18
25051684030004BioFloH96546042046-0422025-03-18
25051684030011BioFloH96546043046-0432025-03-18
25051684009659Soft-VuH787107320020107320022025-03-03
15051684016858BioFlo VortexCT50STBANFVI2024-11-19
15051684016865BioFlo VortexCT50STBAVI2024-11-19
15051684019019ADx Guidewire8101382602024-11-11
H7878101351500ADx8101351502021-01-06
H7878101352600ADx8101352602021-01-13
H7878101381500ADx8101381502021-01-13
H7878105251500ADx8105251502021-01-13
H7878105252600ADx8105252602021-01-06
H7878105321500ADx8105321502021-01-06
H7878105350800ADx8105350802021-01-06
H7878105351500ADx8105351502020-11-25
H7878105351800ADx8105351802020-11-25
H7878105352600ADx8105352602020-11-25
H7878105381500ADx8105381502021-01-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450788407Impress®Merit Medical Systems, Inc.DQO2026-03-21
10884450787080Impress®Merit Medical Systems, Inc.DQO2026-03-19
50690103218607SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
10884450710729Impress®Merit Medical Systems, Inc.DQO2026-03-11
20841156111486LANGSTONTELEFLEX INCORPORATEDDQO2026-03-11
10884450787103Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450787455Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450788070Impress®Merit Medical Systems, Inc.DQO2026-02-19
10884450787653Impress®Merit Medical Systems, Inc.DQO2026-02-14
10884450852849Impress®Merit Medical Systems, Inc.DQO2026-02-14
50690103000417SWAN-GANZEdwards Lifesciences LLCDQO2026-01-30
00884450722329Impress®Merit Medical Systems, Inc.DQO2026-01-28
10884450787516Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450788124Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450787059Impress®Merit Medical Systems, Inc.DQO2026-01-22
10884450787837Impress®Merit Medical Systems, Inc.DQO2026-01-22
04987350744487DUALVIEWTERUMO CORPORATIONDQO2026-01-21
10884450787271Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787530Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450788797Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787721Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787745Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787707Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450787752Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450835934Performa®Merit Medical Systems, Inc.DQO2026-01-03
10884450787813Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787820Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450788650Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450787387Impress®Merit Medical Systems, Inc.DQO2025-12-20