VAXCEL PICC WITH PASV VALVE TECHNOLOGY
FDA 510(k) clearance K021704 · decided 2002-06-06
Clearance details
- K-number
- K021704
- Device name
- VAXCEL PICC WITH PASV VALVE TECHNOLOGY
- Applicant
- Catheter Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-23
- Decision date
- 2002-06-06
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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