FDA.reportPublic FDA data

ENVOY

Primary DI
10886704075103
Brand
ENVOY
Company
Medos International Sàrl
Model
671-260-05DB
Catalog number
67126005DB
Device description
ENVOY DA XB Guiding Catheter STR 105cm 6F (2.0mm) 0.071 Inches (1.8mm)
Published
2016-06-30
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140080000ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XBCodman & Shurtleff, Inc.2014-04-24DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704075103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670407510310886704075103

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
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
10878528000645ENVOY671-260-95D67126095D2016-06-30
10878528000652ENVOY671-258-95D67125895D2016-06-30
10878528000669ENVOY671-260-05D67126005D2016-06-30
10878528000676ENVOY671-258-05D67125805D2016-06-30
10878528000898REVIVERC044115RC0441152016-06-30
10878528000911REVIVERC044130RC0441302016-06-30
10878528000942REVIVERC056115RC0561152016-06-30
10878528000959REVIVERC056125RC0561252016-06-30
10886704074816ENVOY671-256-05D67125605D2016-06-30
10886704075066ENVOY671-256-95DB67125695DB2016-06-30
10886704075073ENVOY671-256-95D67125695D2016-06-30
10886704075080ENVOY671-256-05DB67125605DB2016-06-30
10886704075097ENVOY671-258-05DB67125805DB2016-06-30
10886704075110ENVOY671-258-95DB67125895DB2016-06-30
10886704075127ENVOY671-260-95DB67126095DB2016-06-30
10886704079248YOGAMC24150ZMC24150Z2017-10-31
10886704079255YOGAMC24150ZBMC24150ZB2017-10-31
10886704079262YOGAMC28150ZMC28150Z2017-10-31
10886704079415YOGAMC28150ZBMC28150ZB2017-10-31
10886704079903YOGAMC32150ZMC32150Z2017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019884Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00389701012896R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
00389701012902R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07