IMED GRAVISET INTRAVASCULAR ADMIN. SET
FDA 510(k) clearance K851360 · decided 1985-05-08
Clearance details
- K-number
- K851360
- Device name
- IMED GRAVISET INTRAVASCULAR ADMIN. SET
- Applicant
- Imed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-04
- Decision date
- 1985-05-08
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.