510(k) K052038 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
| Applicant | Boston Scientific Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 16, 2005 |
| Received | Jul 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2006 | Boston Scientific Corporation The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Terminated |
LIT | None listed |
| Jan 31, 2006 | Boston Scientific Corporation The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades)
mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflat Terminated |
MCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.