PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E— 510(k) K010538
Substantially EquivalentRd Medical Mfg., Inc.
FDA 510(k) clearance K010538 for PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E, Substantially Equivalent on 2001-03-30. Applicant: Rd Medical Mfg., Inc.. Device class: 2.
Clearance details
- Applicant
- Rd Medical Mfg., Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Cuelbra, PR, US
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More clearances from Rd Medical Mfg., Inc.
view allAdverse 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, 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.