VACUETTE HOLDEX
FDA 510(k) clearance K980768 · decided 1998-04-09
Clearance details
- K-number
- K980768
- Device name
- VACUETTE HOLDEX
- Applicant
- Greiner Meditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-27
- Decision date
- 1998-04-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bel Air, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-us recall (Z-2957-2011) | Greiner Bio-One North America, Inc. | 2011-08-08 |
| Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine recall (Z-2198-2008) | Greiner Bio-One North America, Inc. | 2008-09-30 |
| Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposabl recall (Z-2134-2008) | Greiner Bio-One North America, Inc. | 2008-09-11 |