BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER— 510(k) K021735
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K021735 for BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER, Substantially Equivalent on 2002-08-08. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code DQY
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- K024048 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
- K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- K012822 — MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.