The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronioc 7f Launcher Biopsy Guide Catheter, Model La7rvbb, Medtronic 8f Launcher Biopsy Catheter, Model La8rvbb.
| Device ID | K030671 |
| 510k Number | K030671 |
| Device Name: | MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Fred L Boucher |
| Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-03 |
| Decision Date | 2003-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994833235 | K030671 | 000 |
| 00613994768933 | K030671 | 000 |
| 10721902713498 | K030671 | 000 |
| 10721902683104 | K030671 | 000 |