Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)— 510(k) K231363
Substantially EquivalentHantech Medical Device Co., Ltd.
FDA 510(k) clearance K231363 for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010), Substantially Equivalent on 2023-09-27. Applicant: Hantech Medical Device Co., Ltd..
Clearance details
- Applicant
- Hantech Medical Device Co., Ltd.
- Product code
- Code NGT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ningbo, CN
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
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.