INTROSYTE CATHETER
FDA 510(k) clearance K974764 · decided 1998-02-26
Clearance details
- K-number
- K974764
- Device name
- INTROSYTE CATHETER
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-19
- Decision date
- 1998-02-26
- Days to decision
- 69 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
| Record | Firm | Date |
|---|---|---|
| BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. recall (Z-0586-04) | Becton Dickinson Infusion Therapy | 2004-07-20 |
| BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. recall (Z-0587-04) | Becton Dickinson Infusion Therapy | 2004-07-20 |