AMNIOINFUSION CATHETER
FDA 510(k) clearance K862182 · decided 1986-08-25
Clearance details
- K-number
- K862182
- Device name
- AMNIOINFUSION CATHETER
- Applicant
- Michael Reese Hospital and Medical Center
- Decision
- Substantially Equivalent
- Date received
- 1986-06-09
- Decision date
- 1986-08-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KXO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.