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 |