The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-probe Disposable Insert With; Balance Biosurface, Carmeda Bioactive Surface, Trillium Biosurface.
| Device ID | K132730 |
| 510k Number | K132730 |
| Device Name: | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169767003 | K132730 | 000 |
| 00643169766983 | K132730 | 000 |
| 20643169802678 | K132730 | 000 |
| 20643169802661 | K132730 | 000 |
| 20763000419909 | K132730 | 000 |
| 20763000419893 | K132730 | 000 |