The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Sentrant Introducer Sheath With Hydrophilic Coating.
| Device ID | K123990 |
| 510k Number | K123990 |
| Device Name: | SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING |
| Classification | Introducer, Catheter |
| Applicant | MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Kelley Lamke |
| Correspondent | Kelley Lamke MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169150379 | K123990 | 000 |
| 00643169150362 | K123990 | 000 |
| 00643169150355 | K123990 | 000 |
| 00643169150348 | K123990 | 000 |
| 00643169150331 | K123990 | 000 |
| 00643169150324 | K123990 | 000 |
| 00643169150317 | K123990 | 000 |
| 00643169150300 | K123990 | 000 |