APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
FDA 510(k) clearance K051096 · decided 2005-05-17
Clearance details
- K-number
- K051096
- Device name
- APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
- Applicant
- St. Jude Medical, Daig Division, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-29
- Decision date
- 2005-05-17
- Days to decision
- 18 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
+ Add to Predicate Builder ◉ Watch St. Jude Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.