TRELLIS-6 PERIPHERAL INFUSION SYSTEM
FDA 510(k) clearance K071664 · decided 2007-07-13
Clearance details
- K-number
- K071664
- Device name
- TRELLIS-6 PERIPHERAL INFUSION SYSTEM
- Applicant
- Bacchus Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-18
- Decision date
- 2007-07-13
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models recall (Z-1365-2015) | Medtronic Inc. Cardiac Rhythm Disease Management | 2015-04-02 |
| Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT61201 recall (Z-1017-2015) | Covidien | 2015-02-03 |