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 |