TALON INFUSION SET, MODEL IP XXXX
FDA 510(k) clearance K033290 · decided 2004-04-12
Clearance details
- K-number
- K033290
- Device name
- TALON INFUSION SET, MODEL IP XXXX
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-14
- Decision date
- 2004-04-12
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with t recall (Z-0592-2012) | ICU Medical, Inc. | 2012-01-11 |
| IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the steril recall (Z-0593-2012) | ICU Medical, Inc. | 2012-01-11 |
| Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 recall (Z-1166-2007) | ICU Medical, Inc. | 2007-08-16 |