510(k) K931619
K931619 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 20, 1993. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1993
- Date Received
- April 2, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type