Data / Medical devices / United States / Respicardia, Inc.
Respicardia, Inc.: FDA-registered device maker in Minnetonka, MN, United States, 2 510(k) clearances and 1 PMA approval
Respicardia, Inc. is registered with the FDA (registration 3009144177) in Minnetonka, MN, United States. It lists 5 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009144177
- Address
- 12400 Whitewater Dr Ste 150, Minnetonka, MN, United States, 55343
- Owner or operator
- Respicardia, Inc. (10046158)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 10, 2014
- Registered through
- 2026
- Brand names listed
- VANES Delivery System, remede® System, respiguide Delivery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Specification developer | accessdata.fda.gov |
| Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | PSR | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pulse Generator, Permanent, Implantable | NVZ | 3 | Manufacturer for export, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2026 | K260459 | VANES Delivery System (VDS) | DYB | Substantially Equivalent | Zoll Respicardia, Inc. | accessdata.fda.gov |
| October 17, 2013 | K130378 | RESPIGUIDE DELIVERY SYSTEM | DQY | Substantially Equivalent | Respicardia | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 6, 2017 | P160039 | remede® System | PSR | 10 | May 7, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Pulse Generator, Permanent, Implantable
- All makers of Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Percutaneous
- All makers of Introducer, Catheter
Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.