The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Spyscope Access And Delivery Catheter.
| Device ID | K090170 |
| 510k Number | K090170 |
| Device Name: | SPYSCOPE ACCESS AND DELIVERY CATHETER |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Ashley Pyle |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-02-04 |
| Summary: | summary |