FDA.reportPublic FDA data

Sof-Flo Atraumatic Coronary Artery Shunt

Primary DI
00899054002609
Brand
Sof-Flo Atraumatic Coronary Artery Shunt
Company
KDL MEDICAL, INC.
Model
SHT-1225S-C01
Device description
Vessel Shunt 2.50mm Tapered Tip, 12mm Shaft, ST
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972665000CHASE BLOOD VESSEL SHUNTChase Medical, Inc.1997-08-22DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002609008990540026098990540026090899054002609

GMDN Terms#

Term, Definition table
TermDefinition
Surgical intravascular shuntA sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972-783-7005cust_svc@chasemedical.com

Regulatory Flags#

DUNS number
791048924
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002821Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
00899054002838Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
00899054002845Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
00899054002852Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002647Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90162025-02-10
00899054002654Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90192025-02-10
00899054002661Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mmRAA-911262025-02-10
00899054002678Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mmRAA-915262025-02-10
00899054002685Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mmRAA-918262025-02-10
00899054002692Atrial Rake, Reusable, Stainless Steel, 19mm x 24mmRAR-919242025-02-10
00899054002708Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, LongRAR-91924L2025-02-10
00899054002715Atrial Rake, Reusable, Stainless Steel, 29mm x 30mmRAR-929302025-02-10
00899054002722Atrial Rake, Reusable, Stainless Steel, 39mm x 34mmRAR-939342025-02-10
00899054002739Atrial Rake, Reusable, Stainless Steel, 37mm x46mmRAR-939442025-02-10
00899054002814Cobra Surgical Arm, 19cm Length, All Sm Links, Shaft ConnectRSA-91192025-02-10
10899054002828Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
10899054002835Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
10899054002842Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
10899054002859Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002203Triumph Aortic Perfusion CannulaMPH-0022S2017-03-14

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