The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Vascular Catheter, Multi Lumen Models 84640, 84652.
| Device ID | K961336 |
| 510k Number | K961336 |
| Device Name: | MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-07-18 |