FDA.reportPublic FDA data

MITRACLIP

Primary DI
08717648231025
Brand
MITRACLIP
Company
ABBOTT VASCULAR INC.
Model
SGC0701
Catalog number
SGC0701
Device description
G4 Steerable Guide Catheter US
Published
2019-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K190167000
K221397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190167000MitraClip G4 Steerable Guide CatheterAbbott2019-05-29DRA
K221397000MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL2022-09-28DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648231025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648231025087176482310258717648231025

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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), needle 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 can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648216824STEERABLE GUIDE CATHETERSGC0301SGC03012016-09-22
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21

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Primary DI, Brand, Company table
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00810024672615AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672622AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672639AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672646AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672653AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
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00810024672677AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672684AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672691AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672707AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672714AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672721AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672738AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672745AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672752AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672769AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672776AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672783AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672790AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672806AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672813AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672820AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672837AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672844AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06