K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
FDA 510(k) clearance K102890 · decided 2010-10-21
Clearance details
- K-number
- K102890
- Device name
- K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
- Applicant
- Kawasumi Laboratories America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-30
- Decision date
- 2010-10-21
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.