RIGHT ATRIAL CATHETER— 510(k) K930630
Substantially Equivalent for Some IndicationsAkcess Medical Products, Inc.
FDA 510(k) clearance K930630 for RIGHT ATRIAL CATHETER, Substantially Equivalent for Some Indications on 1994-02-07. Applicant: Akcess Medical Products, Inc..
Clearance details
- Applicant
- Akcess Medical Products, Inc.
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- New Brunswick, NJ, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.