The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Sequitor Steerable Guidewire, Models Sqr18xx And Sqr14xx.
| Device ID | K061171 |
| 510k Number | K061171 |
| Device Name: | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX |
| Classification | Wire, Guide, Catheter |
| Applicant | BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-06-02 |
| Summary: | summary |