The following data is part of a premarket notification filed by Medtronic Ablation Frontiers, Llc with the FDA for Achieve Mapping Catheter And Electrical Cable.
| Device ID | K102588 |
| 510k Number | K102588 |
| Device Name: | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC ABLATION FRONTIERS, LLC 2210 FARADAY AVENUE SUIT 100 Carlsbad, CA 92008 |
| Contact | Brenda Clay |
| Correspondent | Brenda Clay MEDTRONIC ABLATION FRONTIERS, LLC 2210 FARADAY AVENUE SUIT 100 Carlsbad, CA 92008 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994763907 | K102588 | 000 |
| 00643169504516 | K102588 | 000 |
| 00643169489097 | K102588 | 000 |
| 00643169489080 | K102588 | 000 |
| 00643169467385 | K102588 | 000 |
| 00643169467378 | K102588 | 000 |
| 00643169345560 | K102588 | 000 |