FDA.reportPublic FDA data

Amplatz Goose Neck™

Primary DI
00763000762469
Brand
Amplatz Goose Neck™
Company
MEDTRONIC, INC.
Model
SK400
Device description
SNARE SK400 MICRO SNARE V02
Published
2024-10-27
Public version status
New
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
K970668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970668000THE AMPLANTZ GOOSE NECK MICROSNAREMicrovena Corp.1998-06-10DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000762469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000762469007630007624697630007624690763000762469

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular extraction catheter-snareA flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length150Centimeter
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914836Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914843Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20