The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Sentrant Introducer Sheath With Hydrophilic Coating.
| Device ID | K171866 |
| 510k Number | K171866 |
| Device Name: | Sentrant Introducer Sheath With Hydrophilic Coating |
| Classification | Introducer, Catheter |
| Applicant | Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Wee Wen Leow |
| Correspondent | Wee Wen Leow Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-22 |
| Decision Date | 2017-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169792722 | K171866 | 000 |
| 00763000716349 | K171866 | 000 |
| 00763000716356 | K171866 | 000 |
| 00763000716363 | K171866 | 000 |
| 00763000716370 | K171866 | 000 |
| 00763000716387 | K171866 | 000 |
| 00763000716394 | K171866 | 000 |
| 00763000716400 | K171866 | 000 |
| 00763000716417 | K171866 | 000 |
| 00763000716332 | K171866 | 000 |
| 00763000716325 | K171866 | 000 |
| 00763000716240 | K171866 | 000 |
| 00763000716257 | K171866 | 000 |
| 00763000716264 | K171866 | 000 |
| 00763000716271 | K171866 | 000 |
| 00763000716288 | K171866 | 000 |
| 00763000716295 | K171866 | 000 |
| 00763000716301 | K171866 | 000 |
| 00763000716318 | K171866 | 000 |
| 00763000716424 | K171866 | 000 |
| 00763000716431 | K171866 | 000 |
| 00643169792647 | K171866 | 000 |
| 00643169792654 | K171866 | 000 |
| 00643169792661 | K171866 | 000 |
| 00643169792678 | K171866 | 000 |
| 00643169792685 | K171866 | 000 |
| 00643169792692 | K171866 | 000 |
| 00643169792708 | K171866 | 000 |
| 00643169792715 | K171866 | 000 |
| 00643169792630 | K171866 | 000 |
| 00643169792623 | K171866 | 000 |
| 00763000716448 | K171866 | 000 |
| 00763000716455 | K171866 | 000 |
| 00763000716462 | K171866 | 000 |
| 00643169792579 | K171866 | 000 |
| 00643169792586 | K171866 | 000 |
| 00643169792593 | K171866 | 000 |
| 00643169792609 | K171866 | 000 |
| 00643169792616 | K171866 | 000 |
| 00763000716233 | K171866 | 000 |