DAIG ELECTROPHYSIOLOGY CATHETER
FDA 510(k) clearance K894500 · decided 1989-09-18
Clearance details
- K-number
- K894500
- Device name
- DAIG ELECTROPHYSIOLOGY CATHETER
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-19
- Decision date
- 1989-09-18
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Daig Corp.
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
| Record | Firm | Date |
|---|---|---|
| St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 recall (Z-0177-2015) | St Jude Medical | 2014-11-06 |