The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Intersept* Oxygen Gas Line Filter.
Device ID | K882136 |
510k Number | K882136 |
Device Name: | INTERSEPT* OXYGEN GAS LINE FILTER |
Classification | Device, Vascular, For Promoting Embolization |
Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Dennie W Dyer |
Correspondent | Dennie W Dyer MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | KRD |
CFR Regulation Number | 870.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-20 |
Decision Date | 1988-08-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20673978555564 | K882136 | 000 |