The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Models 5455l And 5455sl Surgical Cables.
Device ID | K923407 |
510k Number | K923407 |
Device Name: | MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES |
Classification | Electrode, Pacemaker, Temporary |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Contact | John M Otto |
Correspondent | John M Otto MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-10 |
Decision Date | 1992-10-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10681490136362 | K923407 | 000 |
10681490136355 | K923407 | 000 |
20763000181080 | K923407 | 000 |