EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET— 510(k) K010197
Substantially EquivalentExelint International, Co.
FDA 510(k) clearance K010197 for EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET, Substantially Equivalent on 2001-05-14. Applicant: Exelint International, Co.. Device class: 2.
Clearance details
- Applicant
- Exelint International, Co.
- Product code
- Product code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
More clearances from Exelint International, Co.
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.