ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
FDA 510(k) clearance K123153 · decided 2013-04-09
Clearance details
- K-number
- K123153
- Device name
- ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
- Applicant
- Medtronic, Ireland
- Decision
- Substantially Equivalent
- Date received
- 2012-10-09
- Decision date
- 2013-04-09
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Integrity Coronary Stent Systems (P030009/S101) | Medtronic, Ireland | 2022-07-15 |
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| Integrity Coronary Stent System (P030009/S104) | Medtronic, Ireland | 2022-01-27 |
| Integrity Coronary Stent System RX and OTW (P030009/S105) | Medtronic, Ireland | 2021-12-14 |
| Integrity Coronary Stent System Rx and OTW (P030009/S106) | Medtronic, Ireland | 2021-11-16 |
| Integrity Coronary Stent System Rx and OTW (P030009/S103) | Medtronic, Ireland | 2021-05-21 |
| Integrity Coronary Stent System (hereafter called Integrity) (P030009/S102) | Medtronic, Ireland | 2021-05-11 |
| Integrity Coronary Stent System (P030009/S100) | Medtronic, Ireland | 2021-03-12 |