PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E— 510(k) K001102

Substantially Equivalent

Rd Medical Mfg., Inc.

FDA 510(k) clearance K001102 for PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E, Substantially Equivalent on 2000-04-20. Applicant: Rd Medical Mfg., Inc..

Clearance details

Applicant: Rd Medical Mfg., Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2000-04-05
Decision date: 2000-04-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Culebra, PR, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.