FDA.reportPublic FDA data

Respiguide Delivery System

Primary DI
00857688007278
Brand
Respiguide Delivery System
Company
RESPICARDIA, INC.
Model
7120-S
Device description
Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Distal shape; 65 cm Inner Angiographic Catheter with Straight Distal Shape
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130378000RESPIGUIDE DELIVERY SYSTEMRespicardia2013-10-17DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857688007275PackageGS15In Commercial Distribution
00857688007278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085768800727510857688007275
00857688007278008576880072788576880072780857688007278

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+19525404471mlynn@respicardia.com
952-540-4471mlynn@zoll.com

Regulatory Flags#

DUNS number
027887663
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
00857688007384respistim LQS Stimulation Lead, Additional Proximal Tubing41652020-10-09
00857688007001remede System Implantable Pulse Generator10012018-04-30
00857688007063respistim R Stimulation Lead31022018-04-30
00857688007070respistim R Stimulation Lead31032018-04-30
00857688007230respistim LQS Stimulation Lead40652018-04-30
00857688007315remede System Programmer1002A2018-04-30
00857688007322remede System Programming Wand1004A2018-04-30
00857688007339remede System Flexible Programming Wand1004A-F2018-04-30
00857688007346remede System External Pulse Generator10062018-04-30
00857688007391remede EL System Implantable Pulse Generator IS-111002021-08-20
00857688007407remede EL-X System Implantable Pulse Generator Inline Connector16002021-08-20
00857688007414remede EL/EL-X External Pulse Generator1006A2021-08-20
00857688007421Lead Test Adaptor, remede EL-X10072021-08-20
00857688007438respistim R Stimulation Lead, Inline Connector36022021-08-20
00857688007445respistim R Stimulation Lead, Inline Connector36032021-08-20
00857688007452respistim R Stimulation Lead, Inline Connector36522021-08-20
00857688007469respistim R Stimulation Lead, Inline Connector36532021-08-20
00857688007483respistim LQS Stimulation Lead, Inline Connector46652021-08-20
00857688007490respistim LQS Stimulation Lead, Inline Connector46852021-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07290017268316SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268323SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268330SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268361SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268385SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268392SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268408SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268804DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268811DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268828DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268866DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268873DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268880DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268309SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268835DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268842DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268859DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
07290017268002SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268019SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268026SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268033SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10