The following data is part of a premarket notification filed by Respicardia with the FDA for Respiguide Delivery System.
| Device ID | K130378 |
| 510k Number | K130378 |
| Device Name: | RESPIGUIDE DELIVERY SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | RESPICARDIA 12400 WHITEWATER DRIVE SUITE 150 Minnetonka, MN 55343 |
| Contact | Bonnie Labosky |
| Correspondent | Bonnie Labosky RESPICARDIA 12400 WHITEWATER DRIVE SUITE 150 Minnetonka, MN 55343 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857688007278 | K130378 | 000 |