FDA.reportPublic FDA data

AcQGuide

Primary DI
00857042007012
Brand
AcQGuide
Company
ACUTUS MEDICAL, INC.
Model
900002
Catalog number
900002
Device description
AcQGuide® Steerable Sheath
Published
2018-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRACatheter, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162925000AcQGuide Steerable SheathAcutus Medical, Inc.2017-04-06DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857042007012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857042007012008570420070128570420070120857042007012

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(442) 232-6100product.complaints@acutus.com

Regulatory Flags#

DUNS number
844418199
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
00850027837635DiamondTemp Generator Adapter8008188008182022-10-24
00850027837642StabilICE9002219002212022-04-01
00850027837659StabilICE9002189002182022-04-01
00850027837192AcQMap8006988006982022-02-01
00850027837222AcQMap8006958006952022-02-01
00850027837239AcQMap8006968006962022-02-01
00850027837246AcQMap8006978006972022-02-01
00850027837444AcQMap8007108007102022-02-01
00850027837451AcQMap8007398007392022-02-01
00850027837468AcQMap8007428007422022-02-01
00850027837475AcQMap8007458007452022-02-01
00850027837482AcQMap8007488007482022-02-01
00857042007333AcQMap8006018006012022-02-01
00857042007357AcQMap8002558002552022-02-01
00857042007364AcQMap8004058004052022-02-01
00857042007388AcQMap8005318005312022-02-01
00857042007425AcQMap8006048006042022-02-01
00857042007999AcQMap9000009000002022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671991AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024672004AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024670314AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670536AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670543AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670550AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024671342AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671359AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671366AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671373AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671380AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671397AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671403AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671410AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671427AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671434AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671441AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671571AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671588AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671595AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671601AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671618AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671625AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671632AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671649AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671687AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671694AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671700AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671731AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671748AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05