PARSET, MODEL A10001E— 510(k) K992104
Substantially EquivalentRd Medical Mfg., Inc.
FDA 510(k) clearance K992104 for PARSET, MODEL A10001E, Substantially Equivalent on 1999-08-23. 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 all- K010538 — PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
- K001102 — PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
- K000017 — PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
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, 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.