The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Ares Antibiotic-impregnated Catheter.
| Device ID | K110560 |
| 510k Number | K110560 |
| Device Name: | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-02-28 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169288885 | K110560 | 000 |
| 00643169762664 | K110560 | 000 |
| 00643169762657 | K110560 | 000 |
| 00643169762640 | K110560 | 000 |
| 00643169474956 | K110560 | 000 |
| 00643169474949 | K110560 | 000 |
| 00643169474932 | K110560 | 000 |
| 00643169288874 | K110560 | 000 |
| 00643169288867 | K110560 | 000 |