The following data is part of a premarket notification filed by Techdevice Corporation with the FDA for Techdevice Occlusion Balloon Catheter.
| Device ID | K051137 |
| 510k Number | K051137 |
| Device Name: | TECHDEVICE OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Contact | Leigh Hayward |
| Correspondent | Leigh Hayward TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2006-02-24 |
| Summary: | summary |