FDA.reportPublic FDA data

AMPLATZ GOOSE NECK™

Primary DI
00763000225391
Brand
AMPLATZ GOOSE NECK™
Company
EV3, INC
Model
SK400
Device description
SNARE SK400 MICRO SNARE V01
Published
2020-10-16
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
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
00763000225391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000225391007630002253917630002253910763000225391

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, 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 Inner Diameter0.53Millimeter
Catheter Working Length150Centimeter
Device Size Text, specify0
Device Size Text, specify0
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
Special Storage Condition, Specify00Store away from sunlight at room temperature in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169996090TrailBlazer™SC-014-1352017-10-15
00643169996106TrailBlazer™SC-014-1502017-10-15
00643169996113TrailBlazer™SC-018-0902017-10-15
00643169996120TrailBlazer™SC-018-1352017-10-15
00643169996137TrailBlazer™SC-018-1502017-10-15
00643169996144TrailBlazer™SC-035-0652017-10-15
00643169996151TrailBlazer™SC-035-0902017-10-15
00643169996168TrailBlazer™SC-035-1352017-10-15
00643169996175TrailBlazer™SC-035-1502017-10-19
00763000104740TrailBlazer™SC-014-1352019-02-28
00763000104757TrailBlazer™SC-014-1502019-02-28
00763000104764TrailBlazer™SC-018-0902019-02-28
00763000104771TrailBlazer™SC-018-1352019-02-28
00763000104788TrailBlazer™SC-018-1502019-02-28
00763000104795TrailBlazer™SC-035-0652019-02-28
00763000104801TrailBlazer™SC-035-0902019-02-28
00763000104818TrailBlazer™SC-035-1352019-02-28
00763000104825TrailBlazer™SC-035-1502019-02-28
00821684057971TrailBlazer™SC-014-1352016-04-04
00821684057988TrailBlazer™SC-014-1502016-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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