WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)— 510(k) K940396
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K940396 for WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE), Substantially Equivalent on 1994-10-03. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code ESW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code ESW
view all- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
More clearances from Boston Scientific Scimed, Inc.
view all- K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
- K030617 — PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
- K024048 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
- K021735 — BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
- K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Adverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.