The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for 26mm Diameter Hancock* Trocar Blade And Tip.
Device ID | K882479 |
510k Number | K882479 |
Device Name: | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Dennie E Dyer |
Correspondent | Dennie E Dyer MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-16 |
Decision Date | 1988-07-18 |