Fusion Quattro Extraction Balloon— 510(k) K200247
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K200247 for Fusion Quattro Extraction Balloon, Substantially Equivalent on 2020-02-27. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Winston-Salem, NC, US
Recent devices under product code GCA
view all- K253013 — Disposable Stone Retrieval Balloon Catheter
- K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- K212582 — SpyGlass Discover Balloon Dilation Catheter
- K210660 — Stone Retrieval Balloon Catheter
- K200173 — Stone Retrieval Balloon
More clearances from Wilson-Cook Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.