The following data is part of a premarket notification filed by Contego Medical, Llc with the FDA for Paladin Carotid Post-dilation Balloon System With Integrated Embolic Protection (paladin System).
| Device ID | K181128 |
| 510k Number | K181128 |
| Device Name: | Paladin Carotid Post-dilation Balloon System With Integrated Embolic Protection (Paladin System) |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Contego Medical, LLC 3921 Sunset Ridge Rd, Suite 102 Raliegh, NC 27607 |
| Contact | Elizabeth Saylors |
| Correspondent | Debra Cogan QRAC, LLC 14906 Conway Avenue San Jose, CA 95124 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851616007309 | K181128 | 000 |
| 00851616007002 | K181128 | 000 |
| 00851616007477 | K181128 | 000 |
| 00851616007293 | K181128 | 000 |