The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Spycatch Stone Retrieval Basket.
| Device ID | K071066 |
| 510k Number | K071066 |
| Device Name: | SPYCATCH STONE RETRIEVAL BASKET |
| Classification | Dislodger, Stone, Biliary |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY MAILSTOP M11 Marlborough, MA 01752 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY MAILSTOP M11 Marlborough, MA 01752 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-06-29 |
| Summary: | summary |