INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
FDA 510(k) clearance K013073 · decided 2001-11-08
Clearance details
- K-number
- K013073
- Device name
- INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-14
- Decision date
- 2001-11-08
- Days to decision
- 55 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.