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 |