FDA.reportPublic FDA data

Micro Access

Primary DI
H787065072040
Brand
Micro Access
Company
ANGIODYNAMICS, INC.
Model
06507204
Device description
Stainless Steel Guidewire
Published
2016-09-20
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
DQRCANNULA, CATHETER
DQXWIRE, GUIDE, CATHETER
DRCTrocar
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2
DQXWire, Guide, CatheterCardiovascular2
DRCTrocarCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051655000ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.2005-09-12DQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787065072045PackageHIBCC10In Commercial Distribution
H787065072040PrimaryHIBCC0
15051684012065SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401206515051684012065

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter
Outer Diameter0.018Inch

Storage And Handling#

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

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
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
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
15051684029643NanoKnifeH787204001110204001112026-04-30
H787204001110NanoKnife204001112022-10-07
H787204003010NanoKnife204003012016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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07613327508635Synchro SELECTStryker CorporationDQX2020-10-20
07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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