510(k) K941750 ยท FDI Snare, Flexible
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
| Applicant | Boston Scientific Corp, Watertown MA, US |
| Decision | Substantially Equivalent, Nov 1, 1994 |
| Received | Apr 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2012 | Boston Scientific Corporation Boston Scientific Profile Single-Use Pediatric Snare 11mm
UPN Outer Box M00562531
Inner Pouch: M00562530 ,
The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can b Terminated |
FDI | None listed |
| Jun 21, 2012 | Boston Scientific Corporation Boston Scientific Profile Single-Use Pediatric Snare 13mm
UPN Outer Box: M00562551
Inner Pouch: M00562550
The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be Terminated |
FDI | None listed |
| Jun 21, 2012 | Boston Scientific Corporation Boston Scientific Profile Single-Use Pediatric Snare 27mm
UPN Outer Box: M00562571
Inner Pouch: M00562570
The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be Terminated |
FDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.