The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite X Ep System, Advisor Vl Circular Mapping Catheter, Sensor Enabled, Advisor Fl Circular Mapping Catheter, Sensor Enabled, Advisor Hd Grid High Density Mapping Catheter, Senor Enabled.
| Device ID | K202066 |
| 510k Number | K202066 |
| Device Name: | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott Medical One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Alyssa Timmers |
| Correspondent | Alyssa Timmers Abbott Medical One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| Subsequent Product Code | DRF |
| Subsequent Product Code | MTD |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2020-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067032157 | K202066 | 000 |
| 05415067033284 | K202066 | 000 |
| 05415067033291 | K202066 | 000 |
| 05415067033376 | K202066 | 000 |
| 05415067033383 | K202066 | 000 |
| 05415067033390 | K202066 | 000 |
| 05415067033406 | K202066 | 000 |
| 05415067033413 | K202066 | 000 |
| 05415067033420 | K202066 | 000 |
| 05415067032379 | K202066 | 000 |
| 05415067032256 | K202066 | 000 |
| 05415067032249 | K202066 | 000 |
| 05415067032164 | K202066 | 000 |
| 05415067032171 | K202066 | 000 |
| 05415067032188 | K202066 | 000 |
| 05415067032195 | K202066 | 000 |
| 05415067032201 | K202066 | 000 |
| 05415067032218 | K202066 | 000 |
| 05415067032225 | K202066 | 000 |
| 05415067032232 | K202066 | 000 |
| 05415067033437 | K202066 | 000 |
| 05415067033444 | K202066 | 000 |
| 05415067033451 | K202066 | 000 |
| 05415067033604 | K202066 | 000 |
| 05415067033611 | K202066 | 000 |
| 05415067033635 | K202066 | 000 |
| 05415067033642 | K202066 | 000 |
| 05415067033659 | K202066 | 000 |
| 05415067033666 | K202066 | 000 |
| 05415067033673 | K202066 | 000 |
| 05415067034748 | K202066 | 000 |
| 05415067033598 | K202066 | 000 |
| 05415067033581 | K202066 | 000 |
| 05415067033574 | K202066 | 000 |
| 05415067033468 | K202066 | 000 |
| 05415067033475 | K202066 | 000 |
| 05415067033482 | K202066 | 000 |
| 05415067033499 | K202066 | 000 |
| 05415067033512 | K202066 | 000 |
| 05415067033536 | K202066 | 000 |
| 05415067033550 | K202066 | 000 |
| 05415067033567 | K202066 | 000 |
| 05415067034755 | K202066 | 000 |