The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Transseptal Needle And Dilator.
| Device ID | K061070 |
| 510k Number | K061070 |
| Device Name: | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR |
| Classification | Trocar |
| Applicant | HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Contact | Nina Peled |
| Correspondent | Nina Peled HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-10-13 |
| Summary: | summary |