FDA.reportPublic FDA data

SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg

Primary DI
05391530750080
Brand
SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg
Company
DMC MEDICAL LIMITED
Model
SVDS300
Catalog number
FD-1004
Device description
Saphenous Vein Distention System - 300mmHg - Sterile
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K000704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000704000DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.2000-05-19GBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750073PackageGS15In Commercial Distribution
05391530750080PackageGS13In Commercial Distribution
05391530750066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750073053915307500735391530750073
05391530750080053915307500805391530750080
05391530750066053915307500665391530750066

GMDN Terms#

Term, Definition table
TermDefinition
Vein irrigation/distention setA collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
989772017
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
true
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
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerFD-1017NS -1ml PC SyringeFD-1017NS -1ml PC Syringe2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerFD-1018NS - 1ml PC SyringeFD-1018NS - 1ml PC Syringe2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintFD-1078NS 20ml PC SyringeFD-1078NS 20ml PC Syringe2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineFD-1075NS 10ml PC SyringeFD-1075NS 10ml PC Syringe2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeFD-1180NS 3ml Nugen SyringeFD-1180NS 3ml Nugen Syringe2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerFD-1162NS 10ml Nugen SyringeFD-1162NS 10ml Nugen Syringe2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC SyringeFD-1019NS - 1ml PC Syringe2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerFD-1021NS 3ml PC SyringeFD-1021NS 3ml PC Syringe2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerFD-1034NS 20ml PC SyringeFD-1034NS 20ml PC Syringe2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerFD-1092NS 20ml PC SyringeFD-1092NS 20ml PC Syringe2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NSFD-1032NS2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerFD-1031NSFD-1031NS2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerFD-1113NS - 10ml PC SyringeFD-1113NS - 10ml PC Syringe2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintFD-1051NS - 10ml PC SyringeFD-1051NS - 10ml PC Syringe2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerFD-1043NS - 10ml PC SyringeFD-1043NS - 10ml PC Syringe2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerFD-1107NS - 30ml PC SyringeFD-1107NS - 30ml PC Syringe2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerFD-1026NS - 10ml PC SyringeFD-1026NS - 10ml PC Syringe2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerFD-1158NS - 10ml PC SyringeFD-1158NS - 10ml PC Syringe2026-06-01

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Primary DI, Brand, Company table
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