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 |