The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5411b Surgical Cable Adaptor.
Device ID | K885101 |
510k Number | K885101 |
Device Name: | MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Contact | D Kvistad |
Correspondent | D Kvistad MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-12 |
Decision Date | 1989-01-12 |