The following data is part of a premarket notification filed by Contego Medical, Llc with the FDA for Vanguard Iep Peripheral Balloon Angioplasty System With Integrated Embolic Protection.
| Device ID | K181529 |
| 510k Number | K181529 |
| Device Name: | Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection |
| 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 | 2018-06-11 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851616007538 | K181529 | 000 |
| 00851616007460 | K181529 | 000 |
| 00851616007453 | K181529 | 000 |
| 00851616007385 | K181529 | 000 |
| 00851616007156 | K181529 | 000 |
| 00851616007149 | K181529 | 000 |