FDA.reportPublic FDA data

Aveir™

Primary DI
05415067034496
Brand
Aveir™
Company
ST. JUDE MEDICAL, INC.
Model
LSCR111
Catalog number
LSCR111
Device description
Retrieval Catheter
Published
2023-03-03
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
MMXDevice, percutaneous retrieval

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMXDevice, Percutaneous RetrievalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213494000Aveir Retrieval CatheterABBOTT MEDICAL2022-04-01MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067034496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067034496054150670344965415067034496

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac pacemaker extraction catheterA sterile, steerable flexible tube with a distal snaring mechanism intended to be introduced into the right ventricle of the heart, via transcutaneous peripheral venous access (e.g., femoral vein), to remove an implanted intracardiac pacemaker; it may also be used to remove an intracardiac pacemaker that has migrated to the peripheral vasculature. It typically has control handle with flush ports, and a single- or multi-looped snare which emerges from the distal tip of the catheter; it may include devices dedicated to catheter introduction (e.g., introducer, guidewire). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length105Centimeter
Outer Diameter6.8Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00850041730141LimFlow V-CeiverInari Medical, Inc.MMX2024-03-09
20827002132874Gunther TulipCOOK INCORPORATEDMMX2023-12-04
00860008180605ONO Retrieval DeviceOnocor LLCMMX2023-08-04
00850041730004LimFlow V-CeiverInari Medical, Inc.MMX2023-06-26
00884450681732ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
10884450681739ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
00884450681749ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
10884450681746ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
00884450681848ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
10884450681845ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
00884450681725ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
10884450681722ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
00884450681718ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
10884450681715ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
00884450681787ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
10884450681784ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
00884450681763ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
00884450681800ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
00884450681831ONE Snare®Merit Medical Systems, Inc.MMX2022-12-15