The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Attain Select Ii + Surevalve Delivery Catheter System, Attain Command + Surevalve Left Heart Delivery System, Attain Comman + Surevalve Guide Catheters For Left Heart Delivery, C315 Delivery Catheter.
| Device ID | K192712 |
| 510k Number | K192712 |
| Device Name: | Attain Select II + SureValve Delivery Catheter System, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters For Left Heart Delivery, C315 Delivery Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Medtronic Inc Parkmore Business Park West Galway, IE |
| Contact | Sharon Fahy |
| Correspondent | Nicola Reidy Medtronic Inc Parkmore Business Park West Galway, IE |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000160586 | K192712 | 000 |
| 00763000160272 | K192712 | 000 |
| 00763000160265 | K192712 | 000 |
| 00763000160258 | K192712 | 000 |
| 00763000160241 | K192712 | 000 |
| 00763000160234 | K192712 | 000 |
| 00763000160227 | K192712 | 000 |
| 00763000160210 | K192712 | 000 |
| 00763000160203 | K192712 | 000 |
| 00763000160197 | K192712 | 000 |
| 00763000160180 | K192712 | 000 |
| 00763000160173 | K192712 | 000 |
| 00763000160166 | K192712 | 000 |
| 00763000160289 | K192712 | 000 |
| 00763000160296 | K192712 | 000 |
| 00763000160302 | K192712 | 000 |
| 00763000160579 | K192712 | 000 |
| 00763000160562 | K192712 | 000 |
| 00763000160555 | K192712 | 000 |
| 00763000160548 | K192712 | 000 |
| 00763000160531 | K192712 | 000 |
| 00763000160524 | K192712 | 000 |
| 00763000160517 | K192712 | 000 |
| 00763000160357 | K192712 | 000 |
| 00763000160340 | K192712 | 000 |
| 00763000160333 | K192712 | 000 |
| 00763000160326 | K192712 | 000 |
| 00763000160319 | K192712 | 000 |
| 00763000160364 | K192712 | 000 |