Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009144177

FEI Number

3009144177

Entity Name

RESPICARDIA, INC.

City/State/Country

Minnetonka, MN, US

Establishment Address

12400 Whitewater Dr Ste 150, Minnetonka, MN 55343, US

Establishment Type(s)

Manufacture Device in the United States for Export Only,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Respicardia, Inc. (Owner Number: 10046158)

Owner / Operator Contact Address

12400 Whitewater Drive, Suite 150, Minnetonka, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

respiguide Delivery System remede® System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2015-06-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-06-01
PSR	Implanted Phrenic Nerve Stimulator For Central Sleep Apnea	Unknown	Class 3	N/A	2017-11-09
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2014-02-10

Official Correspondent

Kevin Bentley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Respicardia, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

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3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009144177. Last updated year: 2026. Please use registration number 3009144177 when referencing this establishment in official correspondence.