SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING— 510(k) K941895
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K941895 for SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING, Substantially Equivalent on 1994-05-24. Applicant: Scimed Life Systems, Inc..
Clearance details
- Applicant
- Scimed Life Systems, Inc.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.