AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
FDA 510(k) clearance K042623 · decided 2005-01-27
Clearance details
- K-number
- K042623
- Device name
- AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
- Applicant
- St. Jude Medical, Daig Division, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-27
- Decision date
- 2005-01-27
- Days to decision
- 122 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Steril recall (Z-1086-06) | St. Jude Medical / Daig Division | 2006-06-03 |