FDA.reportPublic FDA data

ProStream

Primary DI
00836462000490
Brand
ProStream
Company
Micro Therapeutics, Inc.
Model
41276-01
Catalog number
41276-01
Device description
Multiple Sidehole Infusion Wire
Published
2015-10-09
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
K954020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954020000MICRO THERAPEUTICS SIDEHOLE INFUSION WIREMicro Therapeutics, Inc.1996-01-02KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462000490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462000490008364620004908364620004900836462000490

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], 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 microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length175Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000974077Riptide™MAT-110-1102026-03-30
00763000290702Instant DetacherID-1-52023-01-30
00763000950750Riptide™ Aspiration PumpMAP-10002026-03-09
00763000491772Avyon™ 8FR Balloon Guide Catheter8F-087-85CM2021-04-15
00763000491789Avyon™ 8FR Balloon Guide Catheter8F-087-95CM2021-04-15
00763000915681Riptide™ Aspiration PumpLMT-RAP2025-08-18
00763000925338OnyxTM Liquid Embolic System (LES)105-7100-0602026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)105-7100-0802026-01-02
00847536026834RebarTM105-5081-1532017-04-14
00763000974091Riptide™MAC-12002025-12-13
00763000294236HyperForm104-44202020-08-01
00763000294298HyperForm104-47152020-08-01
00836462002180RebarTM105-5081-1302015-10-09
00847536005471HyperFormTM104-44202016-08-19
00847536005549HyperFormTM104-44702016-04-05
00847536005792HyperFormTM104-47152016-08-14
00836462002197Rebar105-5081-1532015-10-22
00763000294267HyperForm104-44702020-08-01
00763000294328HyperForm104-47702020-08-01
00836462002135Rebar105-5080-1532015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
10351688505620MedexICU MEDICAL, INC.KRA2016-12-29
10351688506856MedexICU MEDICAL, INC.KRA2016-10-12
08714729235118Renegade™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729235125Renegade™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280583Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280590Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280606Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280613Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280620Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280637Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280644Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24