RESPIGUIDE DELIVERY SYSTEM
FDA 510(k) clearance K130378 · decided 2013-10-17
Clearance details
- K-number
- K130378
- Device name
- RESPIGUIDE DELIVERY SYSTEM
- Applicant
- Respicardia
- Decision
- Substantially Equivalent
- Date received
- 2013-02-14
- Decision date
- 2013-10-17
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| remede System (P160039/S011) | Respicardia | 2025-05-07 |
| remede System IPG (P160039/S009) | Respicardia | 2023-11-09 |
| remede® System (P160039/S008) | Respicardia | 2023-03-28 |
| remede® System (P160039/S007) | Respicardia | 2022-01-10 |
| remede System (P160039/S006) | Respicardia | 2021-07-28 |
| remede® System (P160039/S005) | Respicardia | 2019-12-23 |
| remede® System (P160039/S004) | Respicardia | 2019-01-30 |
| Remede® System (P160039/S002) | Respicardia | 2018-11-02 |