FIRST MIDCATH CATHETER
FDA 510(k) clearance K972264 · decided 1997-09-15
Clearance details
- K-number
- K972264
- Device name
- FIRST MIDCATH CATHETER
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-17
- Decision date
- 1997-09-15
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.