TEGO, MODEL D1000
FDA 510(k) clearance K053106 · decided 2006-01-10
Clearance details
- K-number
- K053106
- Device name
- TEGO, MODEL D1000
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-04
- Decision date
- 2006-01-10
- Days to decision
- 67 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 recall (Z-1111-2026) | ICU Medical, Inc. | 2026-01-16 |
| Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for recall (Z-0988-2017) | ICU Medical, Inc. | 2017-01-10 |