POLY-TECH ANGIOGRAPHY CATHETER— 510(k) K862030
Substantially EquivalentPoly-Tech Medical Device Research & Development
FDA 510(k) clearance K862030 for POLY-TECH ANGIOGRAPHY CATHETER, Substantially Equivalent on 1986-08-08. Applicant: Poly-Tech Medical Device Research & Development.
Clearance details
- Applicant
- Poly-Tech Medical Device Research & Development
- Product code
- Code DQO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alvin, TX, US
Adverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.