The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic C315 Delivery Catheter.
| Device ID | K101885 |
| 510k Number | K101885 |
| Device Name: | MEDTRONIC C315 DELIVERY CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 Mounds View, MN 55112 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 Mounds View, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2010-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994749963 | K101885 | 000 |
| 00613994749949 | K101885 | 000 |
| 00613994749925 | K101885 | 000 |
| 00613994749901 | K101885 | 000 |
| 00613994749888 | K101885 | 000 |
| 00613994749864 | K101885 | 000 |
| 00613994749840 | K101885 | 000 |