2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
FDA 510(k) clearance K120981 · decided 2012-05-02
Clearance details
- K-number
- K120981
- Device name
- 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-02
- Decision date
- 2012-05-02
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.