DISPOSABLE SYRINGE FILL TUBE
FDA 510(k) clearance K781334 · decided 1978-08-17
Clearance details
- K-number
- K781334
- Device name
- DISPOSABLE SYRINGE FILL TUBE
- Applicant
- Mallinckrodt Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-02
- Decision date
- 1978-08-17
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inc recall (Z-2081-2012) | Mallinckrodt Inc | 2012-07-26 |
| Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regu recall (Z-0830-2012) | Mallinckrodt Inc | 2012-01-20 |
| Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, In recall (Z-0815-2012) | Mallinckrodt Inc | 2012-01-19 |