IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
FDA 510(k) clearance K980992 · decided 1998-05-28
Clearance details
- K-number
- K980992
- Device name
- IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
- Applicant
- Venetec Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-17
- Decision date
- 1998-05-28
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. B recall (Z-1539-2009) | C.R. Bard, Inc., Urological Division | 2009-06-29 |
| StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. recall (Z-0925-03) | Venetec Intl Inc | 2003-06-12 |