NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
FDA 510(k) clearance K974829 · decided 1998-02-12
Clearance details
- K-number
- K974829
- Device name
- NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-24
- Decision date
- 1998-02-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.