The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Introducer Sheath 12f,14f,15f, Models 3805-012, 3805-014, 3805-015.
| Device ID | K990333 |
| 510k Number | K990333 |
| Device Name: | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 |
| Classification | Endoscope, Neurological |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-03 |
| Decision Date | 1999-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169919789 | K990333 | 000 |
| 20643169919772 | K990333 | 000 |
| 20643169919765 | K990333 | 000 |
| 20613994840336 | K990333 | 000 |
| 20613994840329 | K990333 | 000 |
| 20613994840312 | K990333 | 000 |