CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
FDA 510(k) clearance K053208 · decided 2006-01-30
Clearance details
- K-number
- K053208
- Device name
- CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
- Applicant
- Swemed Lab International AB
- Decision
- Substantially Equivalent
- Date received
- 2005-11-16
- Decision date
- 2006-01-30
- Days to decision
- 75 days
- Clearance type
- Abbreviated
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Billdal, SE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Swemed Lab International AB
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.