FDA.reportPublic FDA data

Sof-Flo Atraumatic Coronary Artery Shunt

Primary DI
00899054002081
Brand
Sof-Flo Atraumatic Coronary Artery Shunt
Company
KDL MEDICAL, INC.
Model
SHT-1218S
Device description
Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft
Published
2017-03-14
Public version status
Update
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
00899054002081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002081008990540020818990540020810899054002081

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.

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
00899054002067Mannequin™ Endoventricular ShaperVRD-0080S2017-05-23
00899054002098Mannequin™ Endoventricular ShaperVRD-0090S2017-05-23
00899054002111Mannequin™ Endoventricular ShaperVRD-0100S2017-05-23
00899054002142Mannequin™ Endoventricular ShaperVRD-0110S2017-05-23
00899054002166SVR System without PatchSVC-0080S2017-05-23
00899054002197Mannequin™ Endoventricular ShaperVRD-0120S2017-05-23
00899054002227Mannequin™ Endoventricular ShaperVRD-0130S2017-05-23
00899054002234Mannequin™ Endoventricular ShaperVRD-0140S2017-05-23
00899054002241Mannequin™ Endoventricular ShaperVRD-0150S2017-05-23
00899054002258Mannequin™ Endoventricular ShaperVRD-0085S2017-05-23
00899054002326SVR System without PatchSVC-0085S2017-05-23
00899054002333SVR System without PatchSVC-0090S2017-05-23
00899054002340SVR System without PatchSVC-0100S2017-05-23
00899054002357SVR System without PatchSVC-0110S2017-05-23
00899054002364SVR System without PatchSVC-0120S2017-05-23
00899054002371SVR System without PatchSVC-0130S2017-05-23
00899054002388SVR System without PatchSVC-0140S2017-05-23
00899054002395SVR System without PatchSVC-0150S2017-05-23
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

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