SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS— 510(k) K961999
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K961999 for SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS, Substantially Equivalent on 1996-11-19. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code DYG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code DYG
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- K233983 — Swan-Ganz Pacing Probe and Catheters +4 more
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- K222117 — Swang-Ganz IQ pulmonary artery catheter
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 DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
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.