FDA.reportPublic FDA data

PulseSpray

Primary DI
15051684013277
Brand
PulseSpray
Company
Angiodynamics, Inc.
Model
H787125004210
Catalog number
12500421
Device description
PulseSpray Infusion System
Published
2024-10-11
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
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163356000Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc.2017-05-30QEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787125004210PreviousHIBCC0
15051684013277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401327715051684013277

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3French
Length90Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
00884450825969Fountain®Merit Medical Systems, Inc.KRA2026-06-24
00884450826560Fountain®Merit Medical Systems, Inc.KRA2026-06-09
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399672PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399702PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399719PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399733PhenomTM Plus CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000270162Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08