TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k) clearance K130904 · decided 2013-10-25
Clearance details
- K-number
- K130904
- Device name
- TRELLIS-8 PERIPHERAL INFUSION SYSTEM
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2013-04-01
- Decision date
- 2013-10-25
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mansfield, MA, 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-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and recall (Z-1018-2015) | Covidien | 2015-02-03 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |