The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Attain Command+surevalve Left Heart Delivery System Attain Command Guide Catheters For Left Heart Delivery,attain Select.
| Device ID | K123153 |
| 510k Number | K123153 |
| Device Name: | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC IRELAND PARKMORE BUSINESS PARK WEST Galway, IE El |
| Contact | Deirdre Mcmahon |
| Correspondent | Deirdre Mcmahon MEDTRONIC IRELAND PARKMORE BUSINESS PARK WEST Galway, IE El |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169143289 | K123153 | 000 |
| 00643169142893 | K123153 | 000 |
| 00643169142886 | K123153 | 000 |
| 00643169142879 | K123153 | 000 |
| 00643169142862 | K123153 | 000 |
| 00643169142855 | K123153 | 000 |
| 00643169142848 | K123153 | 000 |
| 00643169142831 | K123153 | 000 |
| 00643169184190 | K123153 | 000 |
| 00643169184183 | K123153 | 000 |
| 00643169142909 | K123153 | 000 |
| 00643169142916 | K123153 | 000 |
| 00643169143272 | K123153 | 000 |
| 00643169143265 | K123153 | 000 |
| 00643169143258 | K123153 | 000 |
| 00643169143210 | K123153 | 000 |
| 00643169143203 | K123153 | 000 |
| 00643169143197 | K123153 | 000 |
| 00643169143180 | K123153 | 000 |
| 00643169143173 | K123153 | 000 |
| 00643169143081 | K123153 | 000 |
| 00643169184176 | K123153 | 000 |