Respicardia

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009144177	3009144177	RESPICARDIA, INC.	1	N	2026-01-01	12400 Whitewater Dr Ste 150 Minnetonka MN US 55343

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00857688007001	remede System Implantable Pulse Generator - remede System, implantable pulse generator for phrenic nerve stimulation	+19525404471	mlynn@respicardia.com
00857688007001	remede System Implantable Pulse Generator - remede System, implantable pulse generator for phrenic nerve stimulation	+1-952-540-4471	mlynn@zoll.com
00857688007063	respistim R Stimulation Lead - Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias	+19525404471	mlynn@respicardia.com
00857688007063	respistim R Stimulation Lead - Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias	+19525404471	mlynn@zoll.com
00857688007070	respistim R Stimulation Lead - Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias	+19525404471	mlynn@respicardia.com
00857688007070	respistim R Stimulation Lead - Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias	+1-952-540-4471	mlynn@zoll.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
167762	1484691143	P160039	remede® System	PSR	2017-10-06
167762	1813551740	K260459	VANES Delivery System (VDS)	DYB	2026-04-06
167762	1244316144	K130378	RESPIGUIDE DELIVERY SYSTEM	DQY	2013-10-17
167762	1826367346

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DYB	1	2026-04-06
PSR	1	2017-10-06
DQY	1	2013-10-17

PMA#

remede® System

2022-01-10

RESPICARDIA

remede System

2021-07-28

RESPICARDIA

remede® System

2019-12-23

RESPICARDIA

remede® System

2019-01-30

RESPICARDIA

Remede® System

2018-11-02

RESPICARDIA

Remede® System

2018-09-12

RESPICARDIA

remede® System

2017-12-21

RESPICARDIA

remede® System

2017-10-06

RESPICARDIA

PMN#

RESPIGUIDE DELIVERY SYSTEM

2013-10-17

RESPICARDIA

GUDID#

remede System External Pulse Generator - 1006

RESPICARDIA, INC.

2018-04-30

respistim LQS Stimulation Lead, Additional Proximal Tubing - Respiratory stimulation lead. respistim LQS with additional proximal tubing, 65cm; quadpolar; distal bias

RESPICARDIA, INC.

2020-10-09

remede System Implantable Pulse Generator - remede System, implantable pulse generator for phrenic nerve stimulation

RESPICARDIA, INC.

2018-04-30

respistim R Stimulation Lead - Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias

RESPICARDIA, INC.

2018-04-30

respistim R Stimulation Lead - Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias

RESPICARDIA, INC.

2018-04-30

respistim LQS Stimulation Lead - Respiratory stimulation lead. respistim LQS, 65cm; quadpolar; distal bias

RESPICARDIA, INC.

2018-04-30

Respiguide Delivery System - Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Distal shape; 65 cm Inner Angiographic Catheter with Straight Distal Shape

RESPICARDIA, INC.

2018-04-30

remede System Programmer - remede System Programmer for use with remede System implantable pulse generator

RESPICARDIA, INC.

2018-04-30

remede System Programming Wand - remede System Programmer Wand

RESPICARDIA, INC.

2018-04-30

remede System Flexible Programming Wand - 1004A-F

RESPICARDIA, INC.

2018-04-30

respistim LQS Stimulation Lead, Inline Connector - Respiratory stimulation lead. respistim LQS with additional proximal tubing, 85cm; quadpolar; distal bias, inline connector

RESPICARDIA, INC.

2021-08-20

remede EL System Implantable Pulse Generator IS-1 - remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header

RESPICARDIA, INC.

2021-08-20

remede EL-X System Implantable Pulse Generator Inline Connector - remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header

RESPICARDIA, INC.

2021-08-20

remede EL/EL-X External Pulse Generator - 1006A

RESPICARDIA, INC.

2021-08-20

Lead Test Adaptor, remede EL-X - Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads

RESPICARDIA, INC.

2021-08-20

respistim R Stimulation Lead, Inline Connector - Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector

RESPICARDIA, INC.

2021-08-20

respistim R Stimulation Lead, Inline Connector - Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias, inline connector

RESPICARDIA, INC.

2021-08-20

respistim R Stimulation Lead, Inline Connector - Respiratory stimulation lead; respistim R, 50cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector

RESPICARDIA, INC.

2021-08-20

respistim R Stimulation Lead, Inline Connector - Respiratory stimulation lead. respistim R, 50 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias, inline connector

RESPICARDIA, INC.

2021-08-20

respistim LQS Stimulation Lead, Inline Connector - Respiratory stimulation lead. respistim LQS, additional proximal tubing, 65cm; quadpolar; distal bias, inline connector

RESPICARDIA, INC.

2021-08-20