HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING— 510(k) K970938
Substantially EquivalentBiocompatibles Cardiovascular, Inc.
FDA 510(k) clearance K970938 for HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING, Substantially Equivalent on 1997-11-17. Applicant: Biocompatibles Cardiovascular, Inc..
Clearance details
- Applicant
- Biocompatibles Cardiovascular, Inc.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, 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.